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Medicine PTSD

mr peabody

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Ships in Distress in a Raging Storm c1690 by Ludolf Backhuysen


MDMA-assisted psychotherapy for PTSD may have benefits beyond reduction in clinical symptoms

by Eric Dolan | psypost.org | May 7, 2019

New research suggests that MDMA-assisted psychotherapy for post-traumatic stress disorder is associated with several beneficial side effects. In addition to reductions in PTSD symptoms, the treatment may be associated with lasting personal benefits and enhanced quality of life, according to research published in the Journal of Psychoactive Drugs.

“Through my work as a clinical psychologist, I have often witnessed the distress, difficulty functioning, and depleted quality of life associated with severe PTSD for many individuals. Additionally, I have seen the difficulty with which many individuals with PTSD have going through traditional treatments for PTSD,” said William Barone, a clinical psychologist and the senior qualitative researcher on the study.

“I had also been interested in the potential of psychedelic and psychoactive compounds to aid in the therapy process, and the first few phase 2 clinical trials confirmed that MDMA-assisted psychotherapy can have a profound effect on PTSD symptoms beyond anything seen in traditional pharmacotherapy or psychotherapy.”

“I took to develop qualitative research in this field for a number of reasons. There had not been any published qualitative studies in MDMA-assisted psychotherapy for PTSD, and it seemed to be a great opportunity to explore the qualitative perspective that I believe is very important in such a study.”

“While quantitative measures are important for showing that a treatment works and that it is safe, in treatments as nuanced as MDMA-assisted psychotherapy, they can have difficulty picking up key details to understanding how and why the treatment may be effective,”
Barone told PsyPost.

“In addition to gaining that nuanced picture, qualitative studies give the participants a voice, and provide insights into how people are affected in very real ways through their participation in the treatment.”

A clinical trial recently tested the safety and effectiveness of MDMA-assisted psychotherapy in 26 military veterans and first responders with PTSD. For the new study, the researchers interviewed 19 of the participants one year after the end of the trial.

“The Phase 2 clinical trials of MDMA-assisted psychotherapy for treatment-resistant PTSD have shown strong reductions in PTSD symptoms over the year following treatment. Based on our study, there appear to be additional benefits to this treatment beyond reduction of PTSD symptoms,” Barone told PsyPost.

Besides reductions in their PTSD symptoms, many of the participants said that the therapy had led to improvement in their self-awareness and social functioning. The therapy also motivated the participants to try new things and reduced the use of both prescription medication and illicit substances.

The participants also expressed being more open to exploring other treatment options following MDMA-assisted psychotherapy. Prior to the clinical trial, many participants expressed very little motivation to continue any treatments for PTSD or other ailments (as is common in individuals with treatment-resistant PTSD).

“Importantly, even the one participant in our sample who was seen to have not benefited from the treatment, displaying less than a 10% reduction in PTSD symptom scores at one year post-treatment, noted that ‘there is improvement from every one of my problems I had when I first came here. Definitely improvement,'” Barone explained.

“The other major take-away from our article is the importance of qualitative investigations in clinical trials, but especially in the psychedelic sciences. Human experience is generally far too nuanced to be captured by t-scores. Especially when the treatment involves ineffable altered states.”

But the study — like all research — includes some limitations.

“The major caveat with most qualitative studies is that they tend to be based on small samples, and even as such are very time and resource intensive. This means it can be difficult to generalize the results,” Barone explained.

“Furthering the difficulty in generalization, the sample included limited diversity, focusing mainly on War Veterans, but also police and firefighters with trauma in the line of duty.”

“However, qualitative studies do not seek generalizability, but rather seek knowledge on an individual level to understand the experience of a phenomena. In recognizing that these experiences took place we have a better understanding of what to look for in future studies,”
Barone said.

Last year, the Multidisciplinary Association for Psychedelic Studies (MAPS) began efforts to recruit volunteers with severe PTSD for Phase 3 clinical trials of MDMA-assisted psychotherapy.

The recent surge in scientific studies on psychedelics has led to a new interest in qualitative research as well.

“Following this publication there has been an increased interest and focus on developing qualitative research in the psychedelic sciences,” Barone said. “We are especially interested in finding graduate students looking to complete theses and dissertations on similar studies, and will be training researchers to do this work on a range of studies in the coming months.”

 
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mr peabody

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You have the right to try psychedelics

by Brittany Hunter

So long as patients are trying a drug of their own volition and free will, no government should stand in their way.

Suffering from PTSD can feel like you are trapped in a prison built of your own horrific memories. Being held captive within your own mind is a unique form of torture since you can’t run away from it or simply think happier thoughts. The darkness follows you in all things, waiting to be triggered. Something as simple as a smell or a sound is enough to flood your mind with unpleasant memories until you feel as though you are drowning in them.

Once that trigger is pulled, those suffering may say and do things they would not normally do. Locked in survival mode, the mind goes into a state that is trapped somewhere between reality and the realm of memory.

In the United States, it is estimated that during the course of a given year, 5.2 million adults experience Post-Traumatic Stress Disorder. Currently, the only legal treatments available for sufferers of PTSD are prescription anti-depressants and anti-anxiety medications. While these may help curb symptoms of PTSD, the medications themselves come with pages of unwanted side effects, including the very real possibility that these drugs will actually make the situation worse. It is also all too common for these medicines to cause a sufferer to take their own life.

Not to mention, anti-depressants and anti-anxiety medications usually serve to numb the unpleasant feelings. While this helps improve the patient’s mood while taking the medication, it doesn’t help them actually deal with the issues that are causing the discomfort.

Of course, this doesn’t mean that better treatments don’t exist. But it does mean that sufferers would be viewed as criminals if they were to try alternatives not sanctioned by the federal government.

But luckily, after years of persistent pressure from MAPS, the FDA is well along in the approval process for the psychedelic drug methylenedioxymethamphetamine (MDMA). And while the FDA’s newfound acceptance of the substance is definitely a sign of progress, it’s far from perfect. What is, perhaps, most infuriating about the FDA’s decision is that it asks sufferers to wait years for a drug that could dramatically improve their diagnosis after only a few uses.

A "Breakthrough" Treatment

MDMA has been found to have “breakthrough” therapeutic qualities for treating PTSD.

In fact, after the second phase of trials conducted by MAPS, 61 percent of the 107 participants no longer qualified as having PTSD. What is more astonishing is that these results were obtained after only three sessions of MDMA being administered. Also worth mentioning, the participants accepted into this study had treatment-resistant PTSD averaging over a time of 18 years.

In other words, these were patients who for years had seen little to no improvement with traditional methods of treatment. Yet, with just a few doses of the drug, the majority of participants saw life-changing improvements.

MDMA works by increasing levels of serotonin, dopamine, and norepinephrine within the brain and then blocking those chemicals from reuptake. This results in a rush of euphoria and empathy and enhanced emotional and physical sensations. When patients are in a state where they are more at ease than usual, it is easier to address past traumas head-on.

When taken in smaller doses than are typically ingested for recreational use, patients are able to work through the issues that have been holding them back for far too long.

Of course, this information isn’t new. It has been around for decades. But it is the first time the government has bothered to pay attention.

State control

For more than 30 years, organizations like MAPS and scholarly individuals like the psychedelic researcher Dr. James Fadiman have been doing their utmost to spread information on the healing powers of psychedelics like MDMA. However, any progress made towards the accepted use of psychedelics in the field of mental health was completely halted with the passing of the Controlled Substances Act of 1970.

Nixon was no fan of the hippie, free love drug culture that accompanied the America’s involvement in the Vietnam War. He wanted law and order and, to that end, started America’s War on Drugs.

Unfortunately, his lack of understanding of the subject meant that for years psychedelic research was suspended. Those studies that continued underground in spite of the new policies were viewed as merely anecdotal and given no substantial medical attention.

The Controlled Substance Act categorized psychedelic drugs and even cannabis as being “Schedule 1” drugs. According to the federal government, drugs given this designation have a high potential for abuse and have no accepted medical use.

In 2017, most doctors understand the medicinal benefits associated with marijuana. But even considering all the information that is around today, the DEA has doubled down on its outdated position and refused to remove cannabis from the list of Schedule 1 substances.

If marijuana can’t be removed from the list, it seems far-fetched to believe that the DEA would consider downgrading psychedelics. But, since Trump was elected on a platform of deregulation, many psychedelic researchers and activists are hopeful.

Rick Doblin, executive director of MAPS, stated:

"I do feel very optimistic. One of the Trump administration's main things is lower regulation. They're pro business and pro making it easier for Big Pharma to get drugs through the FDA. And that benefits us."

However, while this is great news for psychedelics like MDMA, the benefit of having Big Pharma anxious to make a profit does not bode well for other psychedelics, like Lysergic acid diethylamide (LSD). As Doblin pointed out in a statement he made in 2012, substances like LSD and psilocybin (magic mushrooms) are “off-patent, can't be monopolized, and compete with other psychiatric medications that people take daily."

Unfortunately, this makes its medical use unappealing to pharmaceutical companies. Much like marijuana, which can be cultivated by individuals in their home, big pharma has almost nothing to gain from the legality of these substances. In fact, they have everything to lose since research suggests that psychedelics could remove the need for long-term use of anti-depressants and other drugs associated with improved mental health.

But the legality or government approval status of a drug or substance should not determine whether or not an ailing mental health patient has the right to try experimental treatments. Just as terminally ill patients have advocated for “right to try” policies that would allow them to use experimental drugs not yet approved by the FDA, so should mental health patients be able to try psychedelics at their own risk.

The Right to Try

Headlines touted how wonderful it is that as soon as 2021, MDMA may be available by prescription to those who need it most. While this is most certainly a giant step forward, it is also appalling that those suffering are being asked to wait for a potentially life-changing remedy.

“Right to try” policies are typically crafted for patients who are suffering from a terminal illness and allows them to try experimental treatments. While advocating for “right to try” laws have been an uphill battle, the movement has grown in support over the last several years.

Logically, it follows that if someone has been given a terminal prognosis, the individual in question should be allowed to try experimental treatments regardless of the possible negative side effects. While this is justified by concluding that the patient is already going to die so there is no harm in experimentation, this practice should be extended to all consenting adults.

Each individual is the sole owner of his or her body. As such, no governing body has the legitimate authority to tell a person what they can and cannot consume. Yet, over the course of history, governments have decided that it is their duty to ensure that mankind only consumes substances given an official stamp of approval.

The FDA, the agency responsible for dictating what Americans can safely consume, is the same agency that claims Poptarts are healthier than avocados. When this is partnered with the fact that the DEA has routinely ignored scientific evidence that marijuana has medicinal properties, one has to wonder why this authority has not yet been removed.

Suffering from mental ailments or chronic diseases takes a tremendous toll on the sufferer. When your quality of life is in decline because of these daily struggles it is nothing less than evil to prohibit patients from experimenting with different treatments. The drugs that have been approved for medical use, anti-depressants for example, come with a huge risk of side effects including death.

Psychedelics, on the other hand, have fewer physical side effects and are proving themselves to be more impactful for treating varieties of depression. Yet, because of the illegality of these schedule 1 drugs, any patient caught trying MDMA or LSD outside of a government-sanctioned study is a criminal in the eyes of the law.

Something has to change.

So long as patients are trying a drug of their own volition and free will, no government should stand in their way. Every time we consume anything, even food, there is risk associated. Nothing in life is risk-free. But when you are suffering on a daily basis, that risk is mitigated by the need to live a more fulfilling and happy life.

“Right to try” laws should be championed. Those suffering from mental illness deserve the chance to heal today, not four years from now.

 
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mr peabody

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Could MDMA help with PTSD, depression and anxiety?

by Jesse Noakes | The Guardian | Apr 13, 2019

As Australia’s first trial for psychedelic therapy for terminally ill patients gets under way, a growing movement says it could also help other conditions,

In August 2016 I went to New York for the first time. On the second evening, I was sitting on a long couch on the top floor of an old church. All around me instruments were scattered on the floor – singing bowls, tuning forks, rainsticks, Tibetan bells. At the foot of a wall, carpeted completely in moss, was a large bronze gong.

On the table in front of me two small ceramic bowls contained a capsule of 125mg of pure MDMA and a chilli guacamole with three grams of powdered magic mushrooms stirred through it. I eyed them nervously. I was terrified that I was going to lose my mind but I was more scared that nothing would happen at all, that I was too broken for even this radical treatment.

I’d left Australia to take psychedelics with a therapist. Almost a decade of regular talk therapies for depression had done little to explain why I still felt so numb, trapped and terrified. A few months earlier I’d tracked down a guy online who said that, while it wasn’t a magic bullet, he might have something that would help. I can’t name him because it’s still completely illegal.

He was sitting across from me and after I’d swallowed the contents of both bowls he handed me a padded eye mask and suggested I lie back on the couch. I heard him move across the room in the steamy darkness as I tried to relax and focus on my breathing. Moments later I heard the first strange notes from the gong.

2016 was a breakthrough year for psychedelic therapy, not just for me. In May, a study from the Beckley Foundation in partnership with Imperial College London found that two-thirds of their participants with treatment-resistant depression were in remission a week after a therapy session with psilocybin, the active chemical in magic mushrooms. One participant said: “I found I felt more connected, to myself, other people, nature, life in general. I felt alive, rather than distant and isolated and cut off.”

In November 2016 two US university studies jointly published their findings: 80% of the terminally ill patients who had similar psilocybin sessions experienced significant reductions in depression and anxiety.

The following week the US Food and Drug Administration announced that it was approving the final phase of trials of psychotherapy for post-traumatic stress disorder (PTSD) using MDMA.

Meanwhile, in Australia – nothing. At the end of 2015 Psychedelic Research in Science and Medicine (Prism), a non-profit research association formed in 2011, had its second application for a study of MDMA-assisted psychotherapy knocked back by Deakin University. The email from the deputy vice chancellor for research said: “The university will not engage in research that has the potential to damage its reputation as an ethical organisation.”

Dr Martin Williams, president of Prism and a medicinal chemistry researcher at Monash University, got the message loud and clear. “We realised then that it was going to be a hearts and minds operation on our behalf, that we were going to have to be an advocacy organisation and play the long game,” he says.

The momentum has been building for decades overseas. In 1986 Rick Doblin, a trainee therapist with a PhD from the Harvard Kennedy school, founded the Multidisciplinary Association for Psychedelic Studies (Maps) to overturn the decision by the US Drug Enforcement Agency (DEA) to criminalise MDMA use. Initially a drug used in the 1970s by American therapists to enhance their clients’ feelings of trust and openness during sessions, MDMA’s effects had become too popular to contain and, like LSD a couple of decades before, it broke through into wider culture leading to a blanket ban on recreation and research.

Doblin, a shambling sun-bear of a man with a perpetual smile, initially launched an appeal against the DEA decision through its own legal channels, and won. However, the DEA disregarded the ruling so Maps opted for medicalisation – taking MDMA through several phases of clinical trials to establish its safety and therapeutic efficacy. “I just knew from personal experience, from working with patients, that MDMA was so different, that eventually the truth would come out,” says Doblin. “Did I think it would take 32 years? No.”

It was only last year that the full results of six phase-two trials of MDMA-assisted psychotherapy were published, in Lancet and the Journal of Psychopharmacology. Of 107 patients with treatment-resistant PTSD who were administered the drug in two or three seven-hour sessions, with therapists, eye mask and music, 68% were in remission at the 12-month follow-up. It’s about twice the success rate for the gold-standard treatment for PTSD: prolonged exposure therapy.

MDMA’s therapeutic properties emerge from a combination of factors. Its most acute effect is to significantly dampen the activity of the amygdala, the part of our brain that regulates fear response. While it relieves anxiety and stress, MDMA also sharply increases the brain’s supply of serotonin and oxytocin, the neurotransmitters primarily responsible for mood regulation and social bonding.

A recent study in Nature suggested that MDMA can temporarily return the brain to an early development state of “exuberant brain plasticity” that fosters renewed social reward learning. The American psychiatrist Julie Holland says: “You basically couldn’t design a molecule that is better for therapy than MDMA.”

A former firefighter, Ed Thompson, was overdosing nightly on a combination of booze and benzos when he entered a Maps trial in Charleston, South Carolina, in 2015. The trauma of losing nine colleagues as they fought a warehouse fire beside him, the worst firefighting loss in the US since 9/11, was compounded by a chronic illness afflicting his twin baby daughters.

“My body felt like it was going to explode from the inside out ... I was underwater and drowning,” he told me last year. After three all-day MDMA sessions with two therapists beside him, he no longer met the criteria for PTSD. “It was just an incredible time of healing.”

In 2017 the US Food and Drug Administration declared MDMA a “breakthrough therapy”, and Doblin expects it to be a legal medicine in the US again by 2021. Phase-three trials have begun at 15 sites in the US, Canada and Israel and will roll out across Europe this year after agreement with the European Medicines Agency.

In Australia a proposal for an MDMA trial with just four participants is slowly moving through the approvals process, this time at Edith Cowan University in Perth. Stephen Bright, senior lecturer in addiction studies at the university and vice president of Prism, says it supports the trial, and the wider community is increasingly open to the idea. “The public are generally receptive,” he says. “All the stuff I’m talking about – depression, trauma, addiction – they have been touched by in some way. At the end of the day, the evidence says that psychedelic therapy is effective at treating a range of conditions.”

Nigel Strauss, a Melbourne psychiatrist and trauma specialist who worked with Prism on its failed proposal, says the way psychedelic therapy works is a challenge to prevailing medical assumptions. “Psychedelic drugs are a whole change of perspective,” he says. “These are ‘meaning’ drugs, and the whole concept of meaning eludes people and they think it’s hocus-pocus. These are concepts that don’t fit easily into medical science at the moment … particularly in this country.”

But something has shifted. In January St Vincent’s hospital in Melbourne announced that Australia’s first trial of psilocybin-assisted therapy for 30 people with terminal illnesses will start in coming months. It is believed the mind-expanding and mystical properties of the psychedelic experience might be especially effective at relieving the existential angst and hopelessness that often accompanies a terminal diagnosis. “When you’re working with psychedelics you can reliably expect these deeply embodied transformational moments,” says Rosalind Watts, a clinical psychologist working on the Beckley/Imperial trial.

Williams, who is co-investigator on the St Vincent’s study, which Prism has helped organise, says what has been called the “psychedelic renaissance” overseas is more like the dawning of a new age in Australia, where there is no history of psychedelic research. “It’s definitely a major step forward because … as long as we achieve positive results from the research, then we expect to move that into therapeutic practice in a period of time … perhaps five to 10 years,” he says.

Gillinder Bedi, a senior research fellow at the University of Melbourne who has previously run US studies of the pharmacology of MDMA, says of some advocates: “They are the true believers. Scientists are a little bit uncomfortable with the language that gets used. I don’t think that organisations like Maps coming from the counterculture on the people outside it.”

For Bedi their findings are almost too good to be true: “The results I’ve seen are unique – the effects are really clear. It’s just that they’ve been in small studies and they’ve been conducted by people who have massively vested interests in the whole thing … There’s a part of me that goes, ‘Why did your data end up so neat and nice?’ I’m not sceptical about the rigour of the science, I’m just confused more than anything.”

But Bedi insists that contrary to its reputation MDMA is safe to use therapeutically: “It’s pretty clear now that we can administer it in a controlled environment with appropriate supervision pretty safely.” Psychedelics studies exclude people with a history of psychosis or mania, as well as those with certain medical conditions that the drug effects could exacerbate. “If it’s given to people who are well screened beforehand, those risks can be controlled.”

The Prism team was cagey about the St Vincent’s study until the moment it was announced, but Williams has noticeably relaxed his attitude discussing psychedelics in the Australian context. “I think there’s been a broad shift in the public discourse, which has been this ongoing process, probably since the results of the clinical trials in the US and Europe were first communicated,” he says. “ … It’s thanks to the great groundwork of Maps and others overseas that we’re at the point we are now at all.”

A new non-profit called Mind Medicines Australia launches next month to coordinate training more therapists to meet the potential demand. Williams and Strauss are planning a study of psilocybin for treatment-resistant depression, modelled on UK research.

For more than a decade, the Beckley Foundation has developed groundbreaking psychedelic research in partnership with Imperial College London. They produced the first brain scans of the LSD and psilocybin experience which suggest that, rather than amplifying neural activity as expected, psychedelics appear to selectively inhibit the “default mode network”, which regulates executive brain function like a disciplinarian teacher. When psychedelics take it out of the picture for a period, a whole bunch of new connections and neural activity fires up like exuberant children, allowing a wider range of phenomena to reach conscious awareness. Brain scans of long-term meditators have shown the same pattern.

The novel neural connections facilitated in the psychedelic state can lead to lasting changes. A 2018 Beckley/Imperial study using data from their previous depression trial measured significant increases in the personality domain of “openness”’ three months after the single high dose of psilocybin.

It replicates similar findings from Johns Hopkins University in the US. Albert Garcia-Romeu, who is leading another Hopkins psilocybin study, told me that openness goes hand-in-hand with reductions in symptoms such as rigid negative thinking. “It has shown association with overall happiness and quality of life, so in that regard I think it can be an important piece of the puzzle in terms of psychedelics’ therapeutic potentials,” he says.

Ian Roullier, a participant in the Beckley study of treatment-resistant depression, described how he experienced it: “Depression is a very narrow, restricted state and taking psilocybin really helps you to zoom out a lot more … I felt a lightness within myself and more of a freedom.” Like MDMA for PTSD, psilocybin has just been given “breakthrough therapy” status for treatment-resistant depression and large-scale trials are being rushed through across Europe.

For me, about an hour and a half after I lay down in New York, I took off the eye mask and sat up to a world transformed. For as long as I could remember there had been a wall of glass between the world and me, trapping me in a numb limbo that a litany of talk therapy and medications couldn’t touch.

Like magic, the wall was gone. Everything I looked at had a new clarity and immediacy as I drank it in. It was as though an iron knot of tension in my forehead, which contracted my whole body in its clenching grip, had suddenly dissolved. I felt calm, confident and connected. I didn’t feel like I was tripping – I felt like myself for the first time in years. It was the purest relief I’d ever known.

Almost three years later I’m back living in Fremantle but it’s all changed. I had spent past Western Australian summers in bed, staring at the wall with the blinds down. This year I’m up at five most mornings making the most of the rising sun: gym, swim, long walk on the beach, and in the studio by eight this morning to finish off my edits before uni. I’d always wanted to write but the words wouldn’t come, and while I still have to work bloody hard to keep the show on the road, it’s all flowing now.

 
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mr peabody

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Alexander "Sasha" Shulgin


MDMA shows promise for post-traumatic stress treatment

Neuroscience News | May 30, 2019

An international study involving researchers from UBC Okanagan has shown that MDMA may be a valuable tool for treating post-traumatic stress disorder (PTSD).

Published recently in Psychopharmacology, the study demonstrated substantial improvements in individuals who had not responded to prior treatments, explains UBCO Associate Professor of psychology Zach Walsh. This is also, he adds, the most comprehensive evaluation of the safety and effectiveness of MDMA-assisted psychotherapy for PTSD.

“PTSD symptoms decreased after one session of MDMA together with psychotherapy,” says Walsh, study co-author. He adds that 54 per cent of participants no longer met PTSD criteria after two sessions and that there was also improvement in their symptoms of depression.

The response of participants to MDMA-assisted psychotherapy was compared to those who received small doses or non-drug psychotherapy.

“These findings are promising and indicate the needed for larger studies,” says Walsh.

"Too many people with PTSD struggle to find effective treatment, and use of MDMA in a supportive environment with trained mental health professionals could be an important addition to our treatment options.”

MDMA is a synthetic drug made from a combination of methylenedioxy-methamphetamine. It is a controlled, illegal drug in Canada classified as a stimulant with hallucinogenic properties.

Walsh, as well as researchers from the United States, Switzerland and Israel, examined the results from six clinical trials, involving 103 people. Trial participants included men and women with chronic, treatment-resistant PTSD from a wide variety of causes.

Based on these results, the US Food and Drug Administration granted breakthrough therapy designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review.

The first of two more in-depth clinical trials of MDMA-assisted psychotherapy for PTSD began enrolling participants in November 2018, and aims to have 100-150 volunteers across 15 sites in the US, Canada and Israel. The second trial will take place after an interim analysis of the data from the first trial, and will enrol an additional 100-150 participants. European trials are planned to start in the near future.

Nearly four per cent of all people worldwide will suffer from PTSD during their lifetime. PTSD can be a debilitating disorder, with symptoms including intrusive thoughts and memories, negative effects on thinking and mood, depression, hyperarousal and reactivity, and avoidance. People with PTSD can experience much lower quality of life and relationships, related mental health conditions and suicidal tendencies.

 
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Embracing Ecstasy

by Liza Gross | The Verge | May 22, 2019

On a chilly spring morning in 2017, Boris Heifets took the podium to talk about MDMA in an Oakland, California, hotel ballroom packed with scientists, therapists, patients, and activists. If he noticed the occasional whiffs of incense and patchouli oil coming from the halls of the Psychedelic Science meeting, he didn’t let on. After all, anyone studying the therapeutic benefits of the drug that sparked an underground dance revolution 30 years ago knows that ravers, Burners, and old hippies flock to this meeting. It’s the world’s largest gathering on psychoactive substances.

Ecstasy enthusiasts and university professors alike heard several research teams report that MDMA helped patients recover from post-traumatic stress disorder (PTSD) and other disabling psychiatric conditions after conventional treatments had failed. Meeting rooms buzzed with excited chatter about the prospect of MDMA getting approved as a prescription therapy for PTSD. That could come as early as 2021 if it proves safe and effective in large clinical studies that are just getting underway. For many advocates of this work, regulatory approval can’t arrive too soon.

But Heifets, a Stanford neuroanesthesiologist, had come to lay out an even grander role for the drug federal officials banned in 1985 in a futile effort to quash the burgeoning rave scene. Psychiatric treatments lag decades behind the rest of medicine, even though serious mental disorders carry just as much risk of disability and death as cardiovascular disease, Heifets explained. Psychiatrists desperately need more targeted therapies to give their patients the same kind of rapid, enduring relief that stents and bypass surgery provide for heart patients. He thought they’d benefit from thinking like surgeons. “I don’t want to suggest that we can cure psychiatric disease in 30 minutes in the operating room,” Heifets said. "But we can harness powerful drugs like MDMA that act like a surgeon’s knife to alter consciousness and exorcise psychological demons."

For many at the meeting and in the reemerging field of what some call psychedelic medicine, there’s no reason to look further than MDMA. A few hours after Heifets spoke, two therapists who used MDMA in sessions with 28 PTSD patients in Colorado reported that 19 participants no longer met the criteria for their diagnoses a year after treatment. "MDMA helps melt the walls people hide behind to protect themselves," said Marcela Ot’alora, the principal investigator of the study. "That allows patients to explore the coping strategies that have failed them for so long." Other teams reported encouraging results from small studies using MDMA to alleviate severe anxiety in adults with autism and in people confronting life-threatening illnesses.

"MDMA’s therapeutic power may come from strengthening the bond between therapist and patient by enhancing feelings of trust, emotional openness, and empathy," Heifets told the audience, pointing to the commentary he and his mentor, Robert Malenka, published in the journal Cell. To his surprise, a few therapists approached him after the talk to say they quote the paper to tell their patients that the world needs more empathy.

There’s no question that MDMA is showing therapeutic promise and could potentially help a range of socially debilitating disorders, Heifets allows. But MDMA, an amphetamine derivative, can raise heart rate and blood pressure, which can prove dangerous for people with cardiac and vascular problems. Though ecstasy is almost never pure MDMA, recreational use can cause panic attacks. In rare cases, it can trigger psychosis in susceptible individuals, which is an unnerving experience ravers have shared on Reddit. Such risks, combined with its bad rap as a party drug, may limit its ability to help patients, Heifets cautions. He’s convinced that MDMA has an even greater potential to revolutionize psychiatric care by giving scientists clues about how to develop next-generation drugs. Ideally, those drugs would be more clearly targeted and have fewer risks than MDMA. Potentially, they could even treat more disorders.

If psychiatrists are ever going to catch up with the rest of medicine, they need a better understanding of how the brain works so they can guide it back to health when it breaks down. MDMA is the only psychoactive drug that enhances positive social interactions and empathy. Heifets believes this offers researchers a unique opportunity to probe the brain.

The same properties that make ecstasy-fueled ravers hug between dance grooves also make the drug uniquely suited to help scientists figure out how the brain supports social behaviors. Because its powerful effects don’t last long, researchers can model those behaviors in animals and link them to cellular networks in the brain. "Go to a rave, and you’ll find people glassy-eyed, staring inches from each other’s faces in rapt conversation," Heifets says. What they’re saying doesn’t matter. The deep emotional connection they’re experiencing, however, does. “That’s what we’re after. How can we bottle that?”

If scientists can capture that magic, he believes, they can sidestep the inherent difficulties of working with a demonized substance steeped in the trappings of a subculture that still inhabits the fringes of society. After the Colorado investigators described how they used MDMA in therapy, a woman in the audience complimented them on the power of their aura, which she said was violet blue and “pretty incredible.” After a brief pause, Ot’alora smiled and thanked the woman, who said she works in the Akashic Records, described by adherents as a sort of cosmic transcript of everything that has ever happened in the history of the world.

Talk of auras and Akashic Records comes with the territory at a meeting with “psychedelic” in the name, and most researchers take it in stride. They’re waiting to see if mainstream medicine will embrace MDMA, assuming the promising results from early PTSD studies hold up under the scrutiny of the larger clinical trials. But Heifets doesn’t want to take any chances that shifting political winds will once again shut down work with the still-popular club drug — along with any hope of ushering in a new era of psychiatry.

Heifets works in Malenka’s lab in one of the nation’s largest regenerative medicine facilities. The center was built a decade ago to foster groundbreaking therapies for some of medicine’s most intractable diseases. A massive Chihuly chandelier hangs just inside the center’s front entrance where the sculptor’s trademark glass tendrils evoke the networks of neurons that hold the secrets to health and disease. It’s just a short walk from the lab to the hospital where Heifets spends one day a week tending to brain surgery patients.

Heifets didn’t set out to study a controlled substance. “My mom told me I should never study psychedelics,” he says with an impish grin. “It’s a good way to kill a promising career.”

Still, MDMA piqued his interest even as an undergrad. So when he wandered into Malenka’s lab one day and heard him speaking with a colleague about a controlled substance application to do research with MDMA, he went “full in.”

Heifets was just seven years old in the summer of 1984 when the Drug Enforcement Administration proposed new rules to ban MDMA under Schedule I of the Controlled Substances Act, citing “illicit trafficking,” high abuse potential and “no legitimate medical use.” "By then, ecstasy had become so popular," Heifets says, "that you could buy it with a credit card over the counter at clubs in Texas."

The allure of MDMA’s feel-good effects has captured the imagination of adventurers ever since a trailblazing cadre of psychotherapists started using it in the late 1970s. MDMA was discovered in 1912 by German chemists looking for drugs to stop bleeding. It was rediscovered in 1976 by chemist Alexander Shulgin. The legendary psychedelic chemist famously cataloged the effects of nearly 200 psychedelic compounds he’d made in his home lab. He reported feeling “pure euphoria” on MDMA, which he called his “low-calorie Martini” with the “special magic,” and shared the compound with psychotherapists he thought might find it of use.

Those therapists had seen more than a thousand MDMA-assisted breakthroughs with patients, with no major side effects, by the time the government moved to criminalize the drug. Many of them petitioned federal officials to keep it available for their patients. Philip Wolfson, a San Francisco-area psychiatrist who’d used MDMA in hundreds of therapy sessions, testified that the drug had helped patients in severe emotional distress with a poor prognosis. “I am extremely concerned that this promising new psychotherapeutic agent will be lost to the medical profession,” he said.

The government’s campaign to ban a drug with potential medical benefits caught the attention of the era’s king of daytime talk TV, Phil Donahue. In 1985, he devoted an entire show to MDMA. “It makes you love everybody,” Donahue said. “Now, who doesn’t want to take ecstasy?” Several people on the show explained how MDMA had helped them come to terms with life-threatening illnesses and heal fractured family relationships in therapy. Chicago addiction expert Charles Schuster, however, said he had “great concern” about MDMA because he and his colleagues had found that MDA, a chemical cousin, produced long-term brain damage in rats. “If MDA does this,” Schuster warned, “then I have reason to suspect that MDMA may as well.”

That was all DEA deputy assistant administrator Gene Haislip, who also condemned MDMA on Donahue’s show, needed to hear. A month after appearing on Donahue, Haislip announced an emergency ban on MDMA.

The DEA’s ban effectively shut down research on MDMA’s medical benefits, but it did nothing to stop the explosion of underground ecstasy-fueled parties where DJs prided themselves on spinning the most eclectic electronica. Filmmakers mined raves’ trance-inducing beats and light shows as the backdrop for thrillers, crime capers, documentaries, and love stories. Irvine Welsh of Trainspotting fame explored his fascination with “rolling” on ecstasy in a collection of “chemical romance” stories, one of which was eventually adapted for the big screen.

Meanwhile, Schuster was tapped to head the National Institute of Drug Abuse (NIDA), which showered scientists investigating MDMA’s toxicity with millions of federal dollars. It didn’t take long for the NIDA’s investment to pay off. In 2002, researchers led by George Ricaurte — a co-author on Schuster’s MDA study — reported in the prestigious journal Science that recreational doses of ecstasy could cause permanent brain damage in monkeys and possibly lead to Parkinson’s disease. Psychiatrists familiar with the drug questioned the plausibility of the $1.3 million study, which was funded partly by grants on methamphetamine toxicity. Politicians, meanwhile, cited the research to push the Illicit Drug Anti-Proliferation Act — originally introduced in 2002 by Sen. Joe Biden (D-DE) as the Reducing Americans’ Vulnerability to Ecstasy (RAVE) Act — to imprison and fine club owners and promoters for allowing MDMA on their property.

Five months after Congress passed its anti-rave legislation, Ricaurte reported that he’d mistakenly given his animals meth, not MDMA, and retracted the paper. The fiasco, described as an “almost laughable laboratory blunder,” got its own chapter in the book When Science Goes Wrong: Twelve Tales from the Dark Side of Discovery. But the damage had been done. Federal officials continued to bankroll their preoccupation with proving that MDMA causes brain damage while ignoring known risks along with its healing potential.

It took researchers almost 20 years after the ban to get federal permission to test MDMA as an experimental therapy. But federal agencies don’t fund clinical studies on the drug, forcing researchers to rely on nonprofit sources such as the Multidisciplinary Association for Psychedelic Studies (MAPS).

MAPS director Rick Doblin, who founded the organization in 1986, has been instrumental both in getting the Food and Drug Administration’s permission to test MDMA in people and in shepherding it through the drug approval process. Although MDMA could gain FDA approval for PTSD within two years, Doblin is working to make it available as soon as August under the agency’s expanded access program. "The program gives patients with severe or life-threatening illnesses access to experimental drugs when no other suitable options exist. They’ll have to pay for the drug themselves and recognize that there could be risks since the drug hasn’t been approved yet," Doblin explains.

"To qualify for the trial, patients will need to have PTSD and tried multiple therapies that didn’t work. MAPS is training therapists to work with MDMA, and it’s setting up expanded access sites around the country," Doblin says.

While Doblin’s trying to make up for time lost to restrictive drug laws, Heifets worries about moving too fast. “MDMA might work for a lot of people, but there’s going to be a large subset for whom it may create problems,” he says. The clinical trials exclude people with conditions that MDMA might exacerbate, and they give the drug under closely supervised conditions. Using pure MDMA in this way has revealed minimal risks.

That’s not what concerns Heifets. Rather, he’s concerned about what might happen if MDMA is given in unrestricted, unsupervised settings. "Say therapists use the drug without following the carefully crafted MAPS protocol. Who will help people manage the tidal wave of emotions that come up without feeling overwhelmed? Plus, some psychiatric drugs don’t mix with MDMA, so patients will have to be weaned off their meds," Heifets says. “Who’s watching that process? We’re in new territory here.”

"Ideally, everyone who provides MDMA-assisted therapy will have received MAPS training. But expanding use from a few hundred to the millions of people with PTSD raises the potential for a susceptible person to have a bad reaction that triggers another government backlash,"
Heifets says. “How are we going to avoid that outcome this time?”

That’s why he wants to focus on nailing down the brain networks associated with MDMA’s heightened feelings of emotional closeness and empathy. Learning how MDMA works could point to other treatments, maybe ones with fewer risks.

Heifets knew he wanted to study the brain from an early age. But at medical school, he grew increasingly frustrated with his profession’s failure to help people. During a rotation at the Bronx Psychiatric Center, where most patients had failed to respond to every treatment offered, it hit him just how little doctors knew about the roots of psychological distress. “I was so dissatisfied with our ability to do anything,” he says.

A stint in the operating room gave him hope that he could find a way to help people. "Psychiatrists are stuck with “wimpy,” often ineffective drugs that take weeks or months to kick in," he says. But anesthesiologists have access to the most powerful psychoactive drugs in the hospital and can monitor major changes in consciousness in ways that aren’t possible outside the OR. That’s when he started thinking: what if psychiatrists could harness potent consciousness-altering drugs to heal broken brains the way cardiologists use surgery to repair broken hearts?

“This is really where psychiatry meets anesthesia,” he says. Anesthesiologists rely on potent drugs that quickly alter consciousness so surgical patients don’t feel physical pain. Similarly, psychiatrists working with drugs like MDMA can harness fast-acting mind-bending drugs to mold the brain’s perception of psychological distress. Researchers reported 20 years ago that MDMA, in the proper therapeutic setting, alleviates the fear that prevents patients from revisiting traumatic events, a vital part of the healing process. Exactly how MDMA does that still remains unclear.

A few years ago, the Department of Veterans Affairs declared psychotherapy to be the definitive treatment for PTSD; conventional drugs mostly just mask symptoms. But therapy often fails because people can’t bear to relive their trauma. Studies show an increased risk of suicide for veterans with PTSD. Effectively, people are dying for want of better therapies. The success stories from when MDMA was still legal convinced second-generation researchers like Michael Mithoefer that the drug might jump-start the psychological healing process. But whether it could pass muster as a standard treatment had never been pursued in formal research until Mithoefer, a clinical assistant professor of psychiatry at the Medical University of South Carolina, launched the first study with MAPS nearly two decades ago.

Today Mithoefer, a PTSD specialist, is overseeing clinical trials of MDMA-assisted therapy for hundreds of patients at 15 sites in North America and Israel. If all goes well in these formal studies, MDMA could get the green light from the FDA as a prescription drug for PTSD within two years. He’s cautiously optimistic. “We have to wait to see the results before we can say that we’ve definitively established safety and efficacy,” Mithoefer says. “It’s looking promising, but we need to see what happens.”

To get FDA approval, Mithoefer and his team don’t have to show how MDMA works. (“If we did, Prozac would never have been approved,” he says.) "Still", he says, "there may well be other drugs that are even better than MDMA."

As far as MAPS’s Doblin is concerned, there’s no point in trying to find another MDMA-like drug when the real thing is showing such progress. “Alexander Shulgin tinkered with the molecule in hundreds of different ways, but ended up feeling that of all the ones that he did actually produce MDMA was still the best at what MDMA does,” he says.

Doblin allows that drug companies could potentially improve on MDMA. But they’ve shown little interest in a controlled substance with an expired patent that can’t deliver a fast return on investment. And nonprofits like MAPS don’t have the resources to invest in drug discovery or to produce the amount of safety data the FDA requires.

A lot of that safety data, ironically, came from government efforts to demonize the drug, to no avail. “Big governments all over the world have spent hundreds of millions of dollars trying to identify the risks,” Doblin says. “So we have summarized the world scientific literature on MDMA and presented that to FDA.”

Aside from elevated heart rate and blood pressure, the risks include overheating and water intoxication. But it was nothing like the long-term brain damage NIDA seemed so intent on proving. Doblin envisions a day when MDMA will be available far beyond the clinic for everything from couples therapy to personal growth.

It’s a prospect that concerns some psychiatrists, including Charles Grob who led a recent study using MDMA to ease severe anxiety in autistic adults. "The idea of millions and millions of people taking MDMA “makes me dizzy,” says Grob, director of the Division of Child and Adolescent Psychiatry at Harbor-UCLA Medical Center, Los Angeles. "MDMA needs to be administered by trained professionals in special settings with clear-cut safety parameters," he says. Without these measures in place, he worries about “the whole enterprise going off the rails.”

Marcela Ot’alora, who runs the MAPS PTSD study in Colorado, agrees that MDMA may not be for everybody. About three-quarters of PTSD patients in her study learned to cope with their symptoms, but that leaves a quarter who did not. “It’s great if we can find something else that maybe would help people that are not going to be helped by MDMA,” she says.

That’s another thing that suggests Heifets’ approach might be a good one: finding better treatments depends on getting a better handle on how they work, which is insight that’s missing for most psychiatric drugs.

"Scientists stumbled upon the original antidepressants by accident: patients who took new drugs for tuberculosis in the 1950s reported feelings of euphoria. That led to theories about tinkering with neurotransmitters to improve moods and decades of drug development. That pipeline, however, is now dry," Heifets says.

Both Prozac — a selective serotonin reuptake inhibitor (SSRI) — and MDMA affect the same brain chemical: serotonin, which regulates mood, learning, and memory. But no one gets an insatiable urge to approach strangers after taking Prozac, Heifets points out. Clearly, they act in different ways.

"Psychiatrists have long treated the brain as a chemical soup and enlisted drugs to target one chemical after another," he says. "But those drugs can cause terrible side effects because they’re not specific enough. Increasingly, researchers view psychiatric disorders as changes in the connections between specific groups of cells, or circuits, in the brain. Different regions of the brain talk to each other to support normal responses to everyday events, like meeting strangers or navigating potential threats. When those lines of communication between circuits break down, normal responses do, too. Figuring out how MDMA changes these connections to enhance emotional closeness may help explain what goes wrong in people who can’t manage social situations," Heifets says.

"In general, psychiatry hasn’t paid much attention to how social factors affect mental health," says Harriet de Wit, director of the University of Chicago’s Human Behavioral Pharmacology Laboratory. "Yet depression, schizophrenia, and psychosis, for example, share a strong sense of withdrawal from social interactions and society, even though the underlying process likely differs," she says. "A better understanding of how MDMA works might point to other drugs that can specifically affect the different social processes."

Heifets has been trying to do just that under the guidance of Malenka, a leader in enlisting cutting-edge tools in rodents to understand how changes in brain circuits affect behavior. “Rob’s been my biggest advocate and mentor,” Heifets says. “I’m the only one in the lab working on MDMA.”

“This is where Boris and I bonded,”
Malenka says. “It’s just a fascinating drug that I’ve been wanting to study for, my god, probably over 30 years because I think it’s a window into the brain and how the brain works.”

Malenka believes MDMA could ultimately help people whose illness makes healthy social interactions difficult or impossible. “Imagine going through life where you can’t have a positive social experience,” he says. “MDMA really taps into something that enhances the ability to have the most positive social experience.” But where Doblin sees a role for MDMA for everything from PTSD to personal growth, Malenka sees a powerful compound with the potential to harm as well as heal. "That’s not demonizing the drug," he says, "but recognizing the need to understand the good and the bad." For Malenka, MDMA is like any other substance that can affect brain function. "Drilling into the details of how it works will help clinicians make rational decisions about how to use it," he says.

Toward that end, Malenka hopes the experiments they’re doing in mice will influence the clinical studies by showing, for example, that a specific brain circuit isn’t functioning properly in a specific psychiatric disorder. That, in turn, could suggest new therapies that drug companies would be willing to invest in.

Recent work from Malenka’s lab shows that the release of serotonin in a region of the brain’s “reward circuit” — which reacts to pleasurable activities like eating and sex — can enhance social behavior in mice bred to have autism-like behaviors. Research from other groups working in mice showed that MDMA increases “fear extinction,” a decline in fear responses triggered by trauma, which appears to be critical for successful PTSD therapy.

"MDMA may be acting like a sort of psychological accelerant, hastening changes in the brain that lay the groundwork for recovery. The idea of starting a process as a bridge to healing is a concept that’s been missing in psychiatry," Heifets says. "The trick is figuring out novel or existing drugs that can build that bridge. We probably have a ton of drugs that are already FDA approved that we just don’t know what their potential is,” he says.

Beyond exploring how MDMA works in the brain, psychologists are still figuring out how it works in the therapist’s office. “We’re still kind of waving our hands around,” says de Wit. “There’s general agreement that it’s not just the drug itself, but it’s the combination of how the drug changes the therapeutic interaction. I don’t think we know enough about what happens in therapeutic interactions to know whether it’s something about the connection that the patient feels with the therapist or their willingness to be open about their emotions or whether they feel less judged.”

Whatever is going on is a radical departure from standard psychiatric treatments. Rather than taking SSRIs indefinitely to keep symptoms from returning — assuming they ever go away — patients take just a few doses of MDMA in therapy and experience lasting relief.

At the Oakland Psychedelic Science meeting, where Heifets spoke two years ago, several practitioners emphasized the power of the relationship between therapist and patient to aid recovery. Psychiatrist Philip Wolfson, who urged the DEA to keep MDMA legal in the 1980s, said that MDMA revolutionized psychotherapy in part because therapists had to stay with people for as long as they needed. “That meant we exposed ourselves more as therapists,” he said. “And we changed from the 50-minute hour, which was always repugnant to me.”

Wolfson reported preliminary results from sessions using MDMA in 18 patients facing life-threatening illnesses. His study, like other MAPS-funded studies, involved intensive psychotherapy lasting at least eight hours in three sessions. The initial analysis for a subset of patients showed marked improvement in scores for both depression and fear of dying for those who took MDMA. But patients who took placebos also improved, a result Wolfson attributed to the effects of such intensive psychotherapy. Even so, after he recently finished the full analysis, it was clear that the MDMA group had the bigger drop in anxiety compared to the placebo group. Everyone had the option to do a follow-up MDMA session, he told me. Everyone opted for MDMA, and everyone felt even better as a result.

Ot’alora, the PTSD researcher who handled the compliment on her aura without missing a beat, has seen similar therapeutic breakthroughs without MDMA. But it can take years. "With MDMA sessions, people often show improvement right away," she says, "as the drug gives them the inner resources to work through their trauma. Even people who still had trouble coping with their PTSD symptoms after the treatment said it helped them when nothing else had," she says. “Every single participant I’ve worked with has said, ‘I don’t understand why this is not available to everybody who’s suffering.’”

Researchers feel buoyed by the promising results. Yet they’re keenly aware of the stigma around drugs like MDMA. “Now we have data saying that, yes, this is actually helping. It’s no longer anecdotal,” says Ot’alora. “And there are still people who are incredibly skeptical.”

Blame George Ricaurte’s fateful lab blunder. It doesn’t matter that his paper was retracted. It’s still on the internet, including the NIDA’s website. "Even today," Ot’alora says, "people tell her they read that MDMA causes holes in your brain. And she’s seen both patients and parents of younger patients bristle at the idea of using what they see as a club drug for therapy — until they see the results."

For years, meetings like Psychedelic Science were the only place scientists researching psychoactive drugs were invited to speak. “The government and industry have not put one cent into this research, so it has to be supported by donors,” Mithoefer says.

"Still, attitudes among psychiatrists have changed radically since the first MDMA studies," Mithoefer says. Now, he and his colleagues are presenting their work mostly at mainstream meetings where he’s seeing a lot of excitement around the idea that drugs like MDMA can trigger a therapeutic process with higher rates of success. “And nobody’s bringing up their auras,” he says with a laugh.

And now, scientists who study MDMA don’t have to worry about throwing away their careers.

For Heifets, one of the most intriguing things to come from lab work on MDMA is the notion that a drug can strengthen the bond between patient and therapist. “There’s no real precedent for that in psychiatry,” he says. "And that may be where the path to transforming psychiatry begins: in abandoning the notion that you can treat complex human brain disorders with drugs alone. It’s time to recognize that you can’t treat millions of veterans with PTSD by giving them a pill, whatever it is, and sending them home," Heifets says. "The research on MDMA is showing that you might be able to kick off recovery with a drug, but interaction with other people matters, too. In fact, the relationships with other people — like therapists — may matter even more."

“Fundamentally, there is a need for some kind of human connection,”
he says. “We can’t just farm out all of our psychiatric issues to the drug industry.”

 
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Shortec Stublue!!

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Thanks mate appreciate that. I had this discussed in my pharmacy class a few years ago. Mi5 and 6 have used these methods for years. Also Jason Bourne type shit gene mitochondrial therapy too so my Professor told us.
 

Nicomorphinist

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I find the PTSD situation particularly heartbreaking and I think the way it is being handled in the Western countries with a particular catastrophe with it from all of the imperialist wars and maybe very well from some domestic things is an abomination. The best of the best volunteer for a nearly impossible job and do it professionally even if politicians are being completely ignorant and insane about what they have to do, and then they come home with this rock to push up the mountain.

I am glad to see that there is some research on peri-exposure chemoprophylaxis protocols to make it less likely. Quite some time ago I figured that some combinations of beta blockers, mild stimulants, and weak to midrange opioids with conservative doses of ketamine may do it, and I would not at all be surprised to hear MDMA helps before, during, and after.
 

mr peabody

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PTSD and MDMA: Science and perception

by Eugene Rubin | Psychology Today | Oct 03, 2018

As part of the search for novel psychotherapeutic drugs, some investigators have started studying several categories of drugs that are commonly abused. Multiple research groups have shown that ketamine can lead to rapid improvement of symptoms in severely depressed individuals. This drug can also rapidly decrease thoughts of suicide. Drugs related to ketamine are in advanced stages of clinical trials, and it is likely that several medications derived from the work with ketamine will be approved within the next few years.

There are also ongoing trials involving psilocybin and LSD for treating anxiety, depression, and substance use disorders. Another recreational drug with possible therapeutic benefits is MDMA. Users report increased empathy and euphoria when using the drug, but it can also have adverse side effects, including elevating blood pressure and increasing cardiac arrhythmias.

In an article published in Lancet Psychiatry, Michael Mithoefer and colleagues reported that MDMA, when combined with psychotherapy in a controlled setting, was effective in reducing symptoms of chronic post-traumatic stress disorder (PTSD) in a small study of military personnel and emergency first responders. This phase 2 study, together with other phase 2 trials, has led the FDA to designate MDMA-assisted psychotherapy as a “breakthrough therapy,” potentially hastening its approval as a treatment. It should be noted that the Mithoefer et al. study was sponsored by MAPS. Although members of this group may have potential conflicts of interests, this study was reasonably well-designed and the evaluators and participants were “blinded” to the dose of MDMA administered. Large phase 3, multisite, double-blind, placebo-controlled trials could soon follow.

Chronic PTSD is a relatively common condition in military personnel returning from active duty. However, it can be a difficult illness to treat. Some individuals respond to antidepressants such as sertraline or paroxetine, and some respond to specific types of psychotherapies. Nevertheless, these treatments do not substantially help many individuals suffering from moderate to severe symptoms of PTSD.

Mithoefer’s group examined the effects of MDMA-assisted psychotherapy in a group of 26 military veterans and first responders who scored above a threshold score on a standardized assessment of PTSD and who had experienced symptoms of PTSD for at least 6 months. (In fact, the mean duration of PTSD in this group of people was 7 years.) Study participants were randomly assigned to receive one of three doses of MDMA —30 mg (7 participants), 75 mg (7 participants), or 125 mg (12 participants) —together with time-intensive therapy. The lowest dose (30 mg) was considered to be an active control. Each person received MDMA on two occasions separated by 3–5 weeks. Prior to the first MDMA session, each individual participated in three 90-minute psychotherapy sessions “to establish a therapeutic alliance and prepare participants for the MDMA experience.”

Administration of MDMA was accompanied by an 8-hour session of “non-directive or client-directed psychotherapy.” This was followed by a week of daily phone contact and two 90-minute sessions “aimed at integrating the experience.” By the end of the first phase of this study, each individual had received about 13 hours of therapy not associated with MDMA and 16 hours of therapy accompanying two MDMA treatments. Each participant was assessed with a standardized scale for PTSD, as well as other standardized assessment scales, one month after the last administration of MDMA. True “blinding” of the participants may have been compromised in that there were different behavioral effects of the 75 mg and 125 mg doses compared with the 30 mg dose.

PTSD symptoms were substantially diminished in those receiving 75 mg and 125 mg MDMA when compared to the group receiving 30 mg. Six of the 7 in the 75 mg group and 7 of the 12 in the 125 mg group no longer met criteria for a PTSD diagnosis; only 2 of 7 in the 30 mg group achieved this level of response. Also, global psychological function substantially improved in those receiving 75 mg and 125 mg in comparison to those receiving 30 mg. Results from 75 mg were at least as good as results from 125 mg.

Following the double-blind portion of the study, those who received the 30 mg and 75 mg doses participated in an open-label trial of three additional sessions consisting of 100–125 mg MDMA and accompanying therapy. Those who received the 125 mg dose in the original double-blind portion of the study received one further session. The substantial improvements that occurred one month after the double-blind phase of the study were maintained a year after the open-label phase of the study.

The MDMA treatments appeared to be well tolerated. One person had a serious side effect involving a temporary increase in a cardiac arrhythmia that was possibly related to the study drug. Few individuals dropped out of the study; 24 of the 26 participants remained in the trial for its entire duration.

The exact mechanisms underlying the possible therapeutic benefits of MDMA are unknown. MDMA has strong influences on various neurotransmitter systems including serotonergic functioning, but relating these effects to treatment of PTSD would be speculative. MDMA is thought to increase openness and trust, and the authors suggest that these properties may enhance the effectiveness of the therapy sessions.

The present results are intriguing but have substantial limitations, including the small sample size, lack of true controls, possibility that therapists and participants were not always blind to doses used, and use of sessions to prepare subjects for the MDMA exposure. The authors indicate that larger phase 3 studies are under development. If these studies confirm that MDMA together with psychotherapy over a period of several months can lead to substantial symptomatic and functional improvement in military personnel with chronic PTSD, it would be an exciting and remarkable finding. Going forward it will also be very important to define the risks associated with MDMA when used for therapeutic purposes.

Exploring the therapeutic potential of counterculture drugs is a fascinating story. A small group of individuals have dedicated their careers to this cause. If research by other disinterested, non-conflicted scientists can confirm their findings, then this group will deserve credit for their persistence despite marked political resistance.

https://www.psychologytoday.com/us/blog/demystifying-psychiatry/201810/ptsd-and-ecstasy-science-and-perception
 
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mr peabody

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Portraits of veterans and first responders who have committed suicide.


VA approves psychedelic ketamine for PTSD

by Billy Cox | Herald Tribune | Jun 30 2019

SARASOTA — This month’s decision by the U.S. Department of Veterans Affairs to offer a psychedelic drug to treat post-traumatic stress disorder while marijuana remains off limits is leaving some stakeholders flummoxed amid the ongoing wave of veteran suicides.

Spravato, derived from the family of anesthetic drugs called ketamine and produced by a division of Johnson & Johnson, will be prescribed to VA clients on a case-by-case basis and administered as a nasal spray.

Ketamine variants have made headlines over the decades for their multiple roles as sedatives, recreational hallucinogens and for their impressive track records for mitigating suicidal depression. The Spravato version, which was approved by the U.S. Food and Drug Administration in March, requires patients to remain under professional observation for two hours following ingestion.

The addition of a new remedy for lowering military suicide rates at a moment when retired and active-duty personnel are killing themselves roughly 20.6 times a day was hailed as a milestone by VA Secretary Robert Wilkie. “We’re pleased to be able to expand options for veterans with depression who have not responded to other treatments,” he said in a statement. “It reflects our commitment to seek new ways to provide the best health care available for our nation’s veterans.”

But for those like Sean Kiernan, an Army veteran who attempted to take his life in 2011, the VA’s simultaneous embargo on marijuana is incoherent.

“Ketamine was the most effective drug I’ve ever taken for suicidal thoughts — but it is not a long-term medicine you should use. I got psychologically addicted to it for four years,” says Kiernan, president of the Weed For Warriors Project, which advocates legal cannabis for veterans, with 12 chapters nationwide.

“The danger with ketamine is the side effects, like on your urinary tract and gall bladder. I’ve had three surgeons telling me I need to have my gall bladder removed. My question is, why are you so willing and eager to accept something that, on the face of it, is the very thing you complain about with marijuana, like THC, which isn’t nearly as strong? This is hypocrisy, and it makes no sense.”

Catch-22 for veterans

The nation has been struggling with that contradiction since marijuana was classified as a Schedule 1 drug with the Controlled Substances Act of 1970.

The Herald-Tribune documented the Catch-22 that many veterans find themselves in and the effort of proponents to change the law last year in its “Warriors Rise Up” project.

Despite the fact that more than 2.5 million Americans are legally using medical marijuana for ailments as disparate as fibromyalgia and cancer, all drugs labeled Schedule 1 are regarded as having no medicinal value. Ketamine is a Schedule 2 substance.

CNN reported in February that the military suicide virus is now beginning to sweep the ranks of America’s elite warriors, with U.S. Special Operations Command counting 22 self-induced fatalities in 2018. Eight SOCOM operators took their lives the year before. Also, in April, the self-inflicted gunshot death of a 68-year-old veteran in a VA parking lot in Virginia brought to 22 the number of veterans who’ve killed themselves at VA facilities in the past 20 months.

For researchers like Brad Burge, however, the willingness of establishment medicine to employ psychedelics for the treatment of PTSD and associated psychological issues bodes well for the future of marijuana. “It is good news,” he says. “It shows that things are changing in the acceptance of these drugs for mental illness.”

Burge is director of strategic communications for the Multidisciplinary Association for Psychedelic Studies. Founded in 1986 by New College alum Rick Doblin, MAPS is establishing scientific and legal foundations for the expanded use of psychedelics and cannabis.

The nonprofit research organization is completing Phase 3 trials on MDMA-assisted therapy. That drug, also commonly known as Ecstasy, is a controversial synthetic stimulant banned in 1985. MAPS is also studying the therapeutic applications of LSD, and it hopes to get funding for investigating Ibogaine- and Ayahuasca-assisted therapy.

Early this year, MAPS completed its first study of medical marijuana on 76 veterans diagnosed for PTSD, and will publish its results before the end of 2019. But until cannabis loses its Schedule 1 status, gaining access to acceptable samples of marijuana for the completion of MAPS’ research will be difficult.

“But things are changing,” says Burge. “The heads of all these administrative bodies have acknowledged there are limitations that shouldn’t be there. They don’t want to be put in the position of obstructing legal research.”

*From the article here:

 
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Treating the effects of trauma with cannabis

Michelle Thiessen and Sarah Daniels | CHACRUNA

We are all impacted by experiencing or witnessing traumatic events such as violence, accidents, and the death of loved ones. As we struggle to find ways to deal with the symptoms that can persist in the aftermath of experiencing trauma, cannabis is increasingly being hailed as a potential solution. Nearly 90% of adults in the USA have experienced a traumatic event severe enough to meet criteria for post-traumatic stress disorder (PTSD). Of those of us who experience such a trauma, nearly 10% go on to develop full-fledged PTSD, a disorder that involves difficulty recovering from the traumatic event, and includes feeling irritable and jumpy, avoiding reminders of the trauma, intrusive memories, nightmares, insomnia, anxiety, and a pervasive sense of doom. In some cases, people may even feel as if the traumatic events are happening again. The symptoms of PTSD are severe on their own but are often made worse as sufferers may withdraw from family and friends, engage in problematic substance use, and experience suicidal impulses. Sadly, a sizeable portion of people who have PTSD do not respond to frontline treatments such as medication and psychotherapy. Due to the severity of PTSD, and the lack of effective treatment for many of those who suffer, the potential for cannabis to treat PTSD has been met with much hope and enthusiasm. Although we are not yet at the point where we can decisively say that cannabis is helpful for treating PTSD, research that can help answer this question is underway. As we wait for further results, a number of interesting findings have led scientists to believe that cannabis may help some people who struggle with the aftermath of trauma. In this article, we will take a look at some of the science behind the claims that cannabis can help treat PTSD.

People with PTSD using more cannabis

One way of understanding whether cannabis might help with PTSD is to examine naturally occurring cannabis use among people with PTSD. Surveys clearly show that individuals living with PTSD are more likely to use cannabis than those without the disorder. The behavior of people with PTSD involves efforts to cope with the disorder, and as such, elevated rates of cannabis use may suggest that these people feel that cannabis is helping to relieve their PTSD symptoms. Veterans are more likely than the general public to experience a traumatic event due to the nature of their work, and report using cannabis to help deal with the after effects of military-related PTSD. One survey found that more than half of veterans surveyed reported using cannabis, and one in ten said they used cannabis specifically to relieve symptoms caused by their trauma. Another study of veterans found that those experiencing less symptom recovery from traditional therapies were more likely to use cannabis, and that higher levels of PTSD symptoms are associated with more cannabis use, which may suggest that cannabis is being used to treat more persistent symptoms. Individuals with PTSD also report using cannabis to help with PTSD symptoms such as problems with sleep and mood. Taken together with the many informal reports from organizations that support people with PTSD in using cannabis therapies, the use of cannabis by people with PTSD suggests that cannabis therapies deserve careful examination as potential PTSD treatments.

Cannabinoids and PTSD: Evidence from inside and outside the human body

The cannabinoids most of us are most familiar with are the molecules produced by the cannabis plant, such as THC and CBD. However, our bodies are also equipped with a specialized system that produces its own cannabinoids. That system is called the endocannabinoid system, and it helps to regulate things like sleep, appetite, and our ability to handle stress. Differences in the endocannabinoid system that are associated with PTSD symptoms can help us to understand how plant-based cannabinoids might help with PTSD. While it is not clear whether a disruption in the endocannabinoid system is a result, cause, or combination of both with regard to PTSD symptoms, people who develop PTSD after experiencing a traumatic event have been found to have differences in their endocannabinoid systems compared to those who experience similar events but don’t develop PTSD. For example, an important study of individuals who were in New York during the 9/11 attacks found that those who went on to develop symptoms of PTSD had lower levels of the body’s self-made cannabinoid, anandamide, in comparison to those who did not develop PTSD. Interestingly, anandamide resembles the THC found in herbal cannabis, which suggests that using external cannabinoids like THC may help to supplement the body’s own internal cannabis system.

What do studies with animals tell us about cannabis and PTSD?

Animals also possess an endocannabinoid system and have their own ways of responding to trauma and stress. Studies of cannabis and stress in animals can provide some clues as to how cannabis use may impact stress response and learning in humans. After exposure to trauma, animals exhibit symptoms similar to those seen in PTSD, such as an amplified startle response and an impaired ability to unlearn conditioned fear responses. Previous studies have found that giving a cannabinoid to animals after exposing them to trauma can relieve these symptoms.

How does cannabis help with PTSD?

One of the key ways that cannabis may help people with PTSD is by improving sleep. Cannabis use can impact dreaming, and among those with PTSD, it may help to reduce the frequent and disturbing nightmares that are among the most distressing symptoms of the disorder. A study of incarcerated men found that nearly three-quarters of inmates with PTSD who took an oral capsule of THC had their nightmares reduce or stop entirely. Reducing nightmares may be particularly important for improving the quality of life of people with PTSD, as better sleep can help to equip people to deal more effectively with other stressors, and may help them be more active in treatment, and with family and friends. In addition to improving sleep and decreasing nightmares, cannabis may help those with PTSD by more generally reducing anxiety and improving mood. However, regular cannabis use can also lead to withdrawal symptoms when cannabis use stops. Symptoms of cannabis withdrawal can include irritability, anxiety, and nightmares. Because symptoms such as these may already be problems for people with PTSD, starting and then stopping cannabis use might ultimately make PTSD worse rather than better. Helping people with PTSD who use cannabis manage their use and potential withdrawal is an important challenge that may play a big role in determining if and how cannabis medicines can be effective treatments for PTSD.

Active studies and the future of research on cannabis and PTSD

Clinical trials are an important method of establishing the effectiveness of a treatment, and completing such clinical trials will be necessary before cannabis can become a recognized treatment for PTSD. There are currently two clinical trials underway in Canada and the United States that, together, will include almost 200 participants with chronic, treatment-resistant PTSD. Both are double-blinded studies using a crossover design and different CBD/THC ratios of cannabis, including a placebo containing only a trace amount of THC. Neither the researchers nor the participants know what potency they are receiving. Both studies also have a six-month follow-up after the active participation has concluded. It is hoped that results from these trials will be available by 2020, if not sooner. Although these results may go a long way toward telling us how cannabis might be helpful for treating PTSD, information from other sources, such as following people with PTSD who use cannabis over the long term, and examining different types of cannabis—and different types of PTSD—will also be needed to help us understand how this complex plant might play a role in treating this complex disorder. Given the prevalence of PTSD, and the lack of effective treatment for many who suffer, such research is very much warranted, particularly in light of preliminary evidence that suggests that cannabis may help with some of the most troublesome symptoms of PTSD.

 
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Can psychedelic drugs treat PTSD?

by Matt Smith | WebMD

Jon Lubecky was running out of options when he checked into a small house-turned-clinic outside Charleston, SC.

The onetime Army artillery sergeant had been struggling with post-traumatic stress since he got home from Iraq, where his post had been shelled so often it was nicknamed “Mortaritaville.” In 2006, near the height of the insurgency and religious violence that followed the U.S. invasion, one of those shells sent shrapnel tearing through the outhouse where he was sitting in the middle of the night.

The shrapnel missed, but the shock of the blast knocked Lubecky out and left him with a traumatic brain injury. When he came home that fall, he found his wife had left him. He made the first of what would be five suicide attempts that Christmas.

“My life was a country song,” Lubecky says.

By the time he got to the clinic door in November 2014, doctors at a Veterans Affairs hospital had him taking half a dozen medications to treat his PTSD, and it wasn’t working. So Lubecky signed up for an experimental treatment he hoped would help: MDMA, a psychedelic drug commonly known as ecstasy or Molly -- a compound that’s been banned for decades.

“And that’s when everything went weird,” he says. “Good, but weird.”

After years underground, psychedelic drugs are getting attention as a potential treatment for depression and post traumatic stress disorder (PTSD).

MDMA, also known as ecstasy, has shown promise in studies of combat veterans. Psilocybin, the compound in “magic mushrooms” that gets you high, has been tested as a potential boost for people struggling to quit smoking. Researchers in Europe are conducting a survey of how “microdoses” of LSD or other drugs affect mental activity without altering perception. And the American Psychological Association held a symposium in early August on the potential uses of psychedelics.

“This is a very interesting, intriguing moment in psychiatric drug development,” says John Krystal, MD, chairman of the psychiatry department at the Yale University School of Medicine.

Lubecky was part of a trial conducted with the government’s blessing. He went to the house-turned-clinic three times, taking a dose of MDMA in combination with an extensive psychotherapy session. The drug is a form of amphetamine known for producing a sense of openness and emotional warmth, and Lubecky said it helped him discuss his experiences without producing the kind of intense physical responses of PTSD.

“The adrenaline kick didn’t happen. The hair didn’t stand up on my neck,” he says. “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face.” The therapy sessions lasted up to six hours, “but it’s not traumatic at all.”

“There was no ‘A-ha’ moment,”
he says. “It was an incremental change over time, with jumps after each therapy session.”

Doctors have been reluctant to explore the potential uses of psychedelics since the 1960s, Krystal says. Not only did the federal government classify them as having no acceptable medical uses and a high potential for abuse, but many researchers believed they were too powerful to use therapeutically. "But the mental health field is facing “a moment of great need” that’s prompted some rethinking," he says.

“Our appreciation of the seriousness of psychiatric disorders is much more mature than it was then,” Krystal says. “We have a much better understanding about how common, how disabling -- and in some cases, with the rising suicide rate, how lethal these disorders are.”

Over the last 50 years, researchers have made “transformative” advances in understanding how the brain works. "But there haven’t been corresponding breakthroughs in psychiatric drugs," he says. And there have been some promising results so far.

A phase III clinical trial of the use of MDMA to treat PTSD is moving ahead after it won FDA designation as a potential “breakthrough therapy” last summer. That status holds out the prospect of speedy review by the agency and “catapulted” fundraising for the trial’s backers, says Brad Burge, spokesman for the California-based Multidisciplinary Association for Psychedelic Studies (MAPS).

“That breakthrough therapy designation communicates to funders and to the rest of the world that this is a very serious treatment and the FDA is taking it very seriously. That’s huge,” Burge says.

The new study is a follow-up to the one involving Lubecky and another 25 veterans, police and firefighters who took MDMA combined with psychotherapy. "After three doses in controlled settings, nearly all participants saw some improvement in their symptoms -- and about two-thirds “simply didn’t have PTSD anymore,” Burge said.

The results were published in May. Researchers checked in with participants 2 months after treatment, then a year later. "On average, those results actually kept getting better,” Burge says.

In Lubecky’s case, he says his PTSD symptoms are diminished by about 50% on the scale doctors use to assess the condition. Depressive symptoms are down 70%, and he no longer has suicidal thoughts. He’s now an advocate for MDMA therapy and works on veterans issues for MAPS, which he said “saved my life.”

“I was in such a place where I figured my stepson was going to be handed a folded flag off my casket at the age of 14,” he says.

“I know what an impact it’s had on my life,” he adds. “I have close friends of mine who are suffering right now. Anything I can do to grease the skids on that and the get the guys I served with, my guys, the help they need, I’ll do.”

“And now, I get to watch him grow up, drop him off at high school, watch him fall in love, watch him get his heart broke, watch him go to prom and go off to college … then when he’s old, and I’m really old, he’ll get the flag off my casket. And that’s the way it should be.”


There were no serious side effects, but the researchers did find one surprising result: Lower doses of MDMA were less helpful than not being given the drug.

“What we think might be happening there is it could be bringing up emotions or memories in people with PTSD without giving them the additional resources to deal with it in a productive way in therapy,” Burge says.

The FDA last month approved a study testing psilocybin to treat depression. British company COMPASS Pathways plans to begin the phase II trial immediately.

“Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people,” George Goldsmith, chairman of COMPASS Pathways, says in a statement. “It is a huge unmet need, and the trial will teach us more about how this new approach might address it."

Meanwhile, researchers at Johns Hopkins University have been studying the use of psilocybin to help people quit smoking. In follow-up interviews, 15 participants reported “a number of persisting positive effects beyond smoking cessation,” says Matthew Johnson, PhD, associate professor of psychiatry at Johns Hopkins.

“We found generally people claimed vivid insights into their self-identity in psilocybin sessions -- insights into the reasons they smoked,” he says. For most participants, withdrawal symptoms “really took a back seat to their fascination with their unfolding contemplation of these psychedelic sessions."

“I had one pilot participant who said, ‘It’s kind of like I’m in The Matrix and everything’s in slow motion. Here’s a craving that’s coming … instead of that sort of automatic response where my hand goes into my pocket, grabbing a cigarette and it ends up in my mouth, it’s more of a slow, deliberative mindful response.’”


Other participants described increased appreciation or a re-emergence of interest in music and art or poetry.

"Earlier research by Johnson and others at Johns Hopkins found psilocybin can produce 'clinically significant' improvements in depression and anxiety in patients with life-threatening cancer. The drug may be able to provide hope where conventional antidepressant drugs have had little effect," he says.

"But though imaging technology has given researchers the ability to view your brain on drugs, how psychedelic drugs work is still something of a mystery," Burge says.

“Even with MDMA, we have some strong theories about how it might be working to reduce PTSD symptoms in the long run, but we don’t know exactly why,” he says.

"More brain-imaging studies might help to determine the mechanism of action of these drugs," Burge says, "but they’re not needed to get federal approval of a treatment. The FDA only wants to know whether a drug is effective and that the benefits outweigh the risks."

Krystal, who also leads the clinical neuroscience division at the National Center for PTSD at the Department of Veterans Affairs, has warned that the lack of effective drugs to treat posttraumatic stress disorder is a “crisis.” Recent advances in neuroscience may provide a way to reopen the door for psychedelics or drugs like ketamine, which is also being tested as a treatment for depression, but he says that door should be pushed open cautiously.

“I think the central question at the moment is to determine exactly how much of the excitement over the potential therapeutic value of psychedelic drugs is hype and how much of it is real benefit,” Krystal says. “I’m afraid our current research base is so shallow that we have to approach these drugs in a very cautious and exploratory manner.”

https://www.webmd.com/mental-health/news/20180918/psychedlic-drugs-to-treat-depression-ptsd
 

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Nachum Pachenick says MDMA therapy made him a calmer person and "brought me home, to myself."


Israel treating PTSD with MDMA

by Jonah Mandel | Medical Xpress | Aug 21 2019

Nachum Pachenick says he lived a nightmare for nearly two decades after being sexually abused and developing post-traumatic stress disorder—until MDMA therapy came to his rescue.

"It's a life full of stress, pressure, nerves, anxiety, fatigue," the 46-year-old Israeli said from his home in Sde Boaz, a wildcat settlement in the occupied West Bank south of Jerusalem.

"You can't live like that."

Pachenick said relief came in 2014, when he took part in a clinical trial that included the use of MDMA, the active component in the drug known to nightclubbers as ecstasy.

The treatment's success on him and dozens of others has led Israel's health ministry to approve its own pilot for MDMA-assisted therapy for people with treatment-resistant PTSD.

Encouraged by trials so far, therapists involved hold out hope for its future treatment possibilities, though there have also been warnings that further investigation is needed.

Last year, a research team reported in the journal The Lancet Psychiatry that a trial in the United States showed positive results, but stressed such treatment should only be done hand-in-hand with psychotherapy under professional supervision.

During that trial, 85 "adverse events"—including anxiety, headaches, fatigue and insomnia—were reported by 20 participants. It was not clear however whether the MDMA or something else was responsible.

Pachenick had been part of the second phase of three trials conducted in a number of countries under the auspices of the Multidisciplinary Association for Psychedelic Studies.

MAPS hopes to receive approval from the US Food and Drug Administration for the process by 2021.

"The results of the trial's first two phases were extraordinary," said Dr Keren Tzarfaty, a psychologist in charge of training therapists for MAPS in Israel.

"When we look at these people a year after the end of their treatment, we see that 68 percent of the people who received MDMA-combined therapy don't have (PTSD) anymore or are not defined as having PTSD," she said.

"Recovery rates are especially impressive when taking into account the fact that the people who reach us have tried everything," Tzarfaty said from her spacious clinic in the Israeli town of Hod Hasharon.

"Their trauma is resistant to medication, to psychotherapy; they come to us as a last resort."

'Brought me home'

The third and final phase of the trials began in the second half of 2019, and demand far exceeded the mere 14 spots allotted for Israeli participants.

As a result, the Israeli medical establishment has decided to operate its own pilot programme and allow dozens more to receive the treatment, which is done in a controlled setting.

"The Israeli health ministry decided to take the humane and responsible measure to start a pilot of 50 people suffering from PTSD who are resistant to other forms of treatment," said Dr Bella Ben Gershon, in charge of trauma for the Israeli health ministry.

Tzarfaty has facilitated the training of 30 Israeli therapists to work with MDMA.

PTSD is triggered by experiencing an event so traumatic it cannot be fully processed, leaving parts of the brain in a state of hyperarousal and harming its elasticity.

"What MDMA has been found to do is "remove all the defences, but also create lots of compassion to others and oneself," Ben Gershon said.

"The drug can afford the joy and empathy those suffering from PTSD need to begin processing their trauma in the therapy sessions," Tzarfaty said.

The treatment includes 12-15 therapy sessions, all attended by both a male and female mental health professional.

Two or three of the sessions are under the influence of MDMA, administered in the form of a small pill.

While the PTSD of most Israelis taking part in the trial was caused by sexual assault, the country has also fought a series of conflicts, resulting in relatively high rates of the disorder, Ben Gershon said.

"Because of that, she believed the government had a moral duty to do what it could to help those suffering from it," Tzarfaty said.

Most Jewish Israelis must perform mandatory military service.

The current trials with MDMA, a substance created in a laboratory in 1912, are part of the "renaissance" in the research of psychedelic substances and their application in psychiatry over the past decade, Tzarfaty said.

Pachenick said the effects of the treatment on him were dramatic.

"The process put me back on track, but in a more profound way brought me home, to myself," he said.

"I'm a much calmer person today. I have a family that's very dear to me—all these things were very unstable beforehand."

 
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MDMA may reawaken ‘critical period’ to help treat PTSD

Neuroscience News | April 4, 2019

MDMA, a psychedelic drug, has successfully been used to reopen the ‘critical period’ of learning the reward values of social behaviors. Researchers report, in mature mice given MDMA, oxytocin triggers signaling in synapses that help encode social learning and memory, a process that does not usually occur in older animals. The findings could help in the development of treatments for PTSD and other disorders.

Johns Hopkins neuroscientists have found that the psychedelic drug MDMA reopens a kind of window, called a “critical period,” when the brain is sensitive to learning the reward value of social behaviors. The findings, reported April 3 in Nature, may explain why MDMA may be helpful in treating people with post-traumatic stress disorder (PTSD).

Critical periods were first described in the 1930s in snow geese. About 24 hours after a gosling hatches, if mother goose is nowhere to be found, the hatchling will bond with an object, including non-living ones. Yet, if mother goose disappears 48 hours after her gosling hatches, the critical period is over, and the hatchling won’t bond to an object.

There is evidence for critical periods that smooth the way for development of language, touch and vision.

For the current study, neuroscientist Gül Dölen says, “We wanted to know if there was a critical period for learning social reward behaviors, and if so could we reopen it using MDMA, since this drug is well-known to have prosocial effects.”

Dölen studied groups of mice in enclosures with different bedding. They put several mice together in one enclosure with one type of bedding for 24 hours and, in the next 24 hours, put the same mice by themselves in another enclosure with a different type of bedding. The mice began to associate certain types of bedding with isolation or companionship. Then, they let the mice wander between enclosures with the two types of bedding and tracked how long the mice spent in each enclosure. The more time the mice spent in the bedding linked to their companions indicated more social reward learning.

“It’s why people gather around the water cooler,” says Dölen, assistant professor of neuroscience at the Johns Hopkins University School of Medicine. "People are conditioned to know that the water cooler is an optimal place to chitchat with companions."

In their experiments, Dölen and her colleagues found that the critical period for social reward learning in mice is around puberty and wanes once they become mature adults. To determine if they could reopen the critical period, the scientists gave MDMA to mature mice, waited 48 hours for the drug to be washed out of their system, and observed how the mice explored their enclosure and behaved with other mice in the enclosure. Following the treatment with MDMA, most of the animals responded to social interactions the same way as juveniles, by forming a positive association between social interactions and the bedding. This effect lasted for at least two weeks after the MDMA treatment, and it was not observed in mice given saline injections.

“This suggests that we’ve reopened a critical period in mice, giving them the ability to learn social reward behaviors at a time when they are less inclined to engage in these behaviors,” says Dölen.

Dölen and her postdoctoral student and first author of the current study, Romain Nardou, also observed that MDMA works to reopen the critical period only if the drug is given to mice when they are with other mice, not if it is given to mice while they are alone. "This suggests that reopening the critical period using MDMA may depend on whether the animals are in a social setting," say the scientists.

The mice maintained their ability to learn the rewards of social behavior for up to two weeks from the time they were given MDMA. During this time, Dölen and her colleagues also found that the brains of the mice had corresponding responses to oxytocin, known as the “love hormone,” which is made in the hypothalamus and acts in the brain as a signal between neurons that encode information about social rewards. They found these responses by looking more closely at synapses, the spaces between brain cells called neurons. Their experiments showed that, in mature mice given MDMA, oxytocin triggers signaling in the synapses that encodes learning and memory, which does not typically happen in mature mice.

Dölen says that opening the critical window for social reward behavior may also have implications for treating psychiatric conditions. A strong bond between a psychotherapist and patient is well-known to be important for successful treatment. If MDMA reopens the critical period for social reward learning in humans in the same way it does for mice, then it could explain why the drug has been successful in treating people with PTSD, perhaps by strengthening the psychotherapist-patient bond.

MDMA has been designated by the U.S. Food and Drug Administration as a “breakthrough therapy” for PTSD, meaning that the agency will fast-track the development and review of clinical trials to test it. However, the researchers caution that MDMA may not work for every psychiatric condition linked to social behaviors.

“As we develop new therapies or determine when to give these therapies, it’s critical to know the biological mechanism on which they act,” says Dölen.

 

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MDMA healed a first responder’s PTSD

Reality Sandwich | Sep 19 2019

As a first responder, Nick Watchorn had seen many terrible things in the course of his career. But the massive shooting of April 28, 1986 in Tanzania, Australia, completely shook his handle on reality. Now Nick is part of the experimental studies on therapeutic MDMA for PTSD treatment.

The Port Arthur Massacre, which occurred at a popular tourist site, left 35 dead and wounded 23 others. In terms of dealing with their own trauma, first responders were taught to “stay strong.” Equipped only with this attitude, Watchorn did not have any tools to emotionally process the event, and suffered thereafter from Post Traumatic Stress Disorder (PTSD).

Twenty Years with PTSD

It wasn’t just the horror of the event. And, it wasn’t just the memories that haunted him, and woke him in the middle of the night with sweats and a racing heart. It had reshaped his entire worldview. After experiencing the worst side of humanity, he said he lost trust in people, knowing what they were capable of. Likewise, the inability to release an experience so wholly wrapped in fear made him terrified to try anything new. He lived in that fear and mistrust for 20 years, just trying to get by with alcohol, antidepressants, and reckless behavior. He also went to therapy, but his PTSD symptoms persisted.

Nick finally experienced relief from his PTSD while partaking in a Phase III clinical trial conducted by The Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS spearheads research to study the possibilities of MDMA for PTSD sufferers, like Nick. Nick had 3 trials sessions. Taking an MDMA pill at the beginning of each, he then received psychotherapy treatment from Stephen Eric Sienknecht, Psy.D. While the effects of regular therapy sessions had dissipated within hours, these MDMA-induced sessions had lasting effects. Namely, he no longer feels PTSD symptoms. After 20 years, Nick feels free.

Street MDMA vs medical MDMA

MDMA is currently classified by the Drug Enforcement Agency (DEA) as a “Schedule I drug.” The substances that fall into this category are considered to have no medical use, and a high potential for abuse. Because of its illegality, MDMA consumers must buy it on the so-called black market. Accordingly, it is almost impossible to find the substance in pure form. Ecstasy found on the street can contain a variety of other substances, usually meant to keep one awake longer–like pain killers, caffeine, ketamine, or even amphetamines. Some of the pills don’t even contain any MDMA in them at all.

The point is – don’t think you can just call up your local drug dealer, order some “E” and resolve all of your traumas. Rather, the FDA has allowed MAPS to conduct clinical trials to administer MDMA in its pure form, which as we established, is hard to come by out there. Also, the subjects are not just sent on their merry way after taking the drugs, as they often are with legal prescription opioids and antidepressants. They must take the pills in the presence of psychotherapists. They stay with the patients throughout their entire “trip,” which can last 6-8 hours, or even overnight. The psychotherapists then prompt the patients to process their traumatic experiences in a new way. But how does that all work? Hold on, we’ll get there.

What is PTSD?

When most people hear PTSD, they think war veterans. That’s one group that has historically suffered from PTSD, without much success in alleviating their pain. And it’s easy to imagine, at least, how utterly overwhelming such an experience as war must be. There are different kinds of experiences however, war being one of them, that can trigger the brain to go into survival mode; that “fight or flight” thing your bio teacher always talked about. Its focus is to keep you alive – first. Thus, it puts the emotions aside for later. The emotions are usually too intense for the brain to process at one time anyway.

But the traumas that PTSD patients experience are so potent that they are difficult to process later, even 20 years later, as in Nick’s case. Instead, an emotional attachment to the memory continues to evolve, as well as a reiteration of fear. It becomes nearly impossible to control one’s thoughts, emotions, or physical symptoms. According to Nick’s psychotherapist, Psy.D Sienknecht, PTSD can even be life-threatening, or at the very least, completely debilitating.

MDMA for PTSD, why does it work?

MDMA basically does two things to the brain. First, it increases activity in the prefrontal cortex, which is responsible for creativity, planning, and critical thinking. It also decreases activity in the amygdala, which is responsible for fear response. Sienknecht describes this dual effect as a “window of tolerance.” In other words, the brain can re-experience the memory of traumas, but in a different way. A way that doesn’t cause re-traumatization by a fired amygdala.

MAPS published the results of Phase II clinical trials in a medical journal. In the Phase II trials, PTSD-affected subjects took MDMA and thereafter received psychotherapy treatment, just as Nick did. They revisited their traumatic memories, experiencing intense pain and anxiety, but with one key difference. They were able to remain emotionally engaged because of the MDMA. The study showed that 58% of participants no longer had PTSD after the trial, and 68% no longer had it a year later. This proof of effectiveness allowed the study to pass to Phase III, which Nick was a part of.

MAPS aims to prove that MDMA has medical and therapeutic benefits for patients with PTSD, like Nick. If they do, it may become the first Schedule I drug that the DEA reclassifies. There are other anxiety disorders, and medical conditions that psychedelics such as MDMA can potentially treat. MAPS, and other institutions around the world, recognize their power to heal trauma–in general. We await to see what other revelations MAPS, and organizations like them, will bring us, as they discover new ways of treating some of the biggest issues plaguing human beings today.

 
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Cambridge


Is ketamine a breakthrough medicine for PTSD?*

Doctors know ketamine as an intravenous anesthetic used most often on children and animals and abused as the party drug sometimes referred to as “Special K.” In the early 1990s, it became clear that slow infusions of ketamine at very low doses gave quick but brief relief to patients with severe depression.

Dr. Krystal noted evidence that ketamine may work especially quickly in people with bipolar depression and offers hope for others in need of new options: people who fail to respond to electroconvulsive therapy, people with a psychotic depression, people with severe anxiety or agitation as well as those with severe pain.

PTSD patients badly need a new solution, he explained: they only see about a 10% reduction beyond placebo with current anti-depressants. Combat-related symptoms are especially tough. The Department of Veteran Affairs funded two large trials of promising drugs, Prasozin and Risperidone, but they proved ineffective. "Moving forward," Dr. Krystal explains, "requires turning to 'a deeper understanding of the biology' underlying depression and PTSD."

Is glutamate the important neurotransmitter in depression and PTSD?

Current anti-depressants boost the availability of serotonin or serotonin and norepinephrine, two neurotransmitters that enable neurons in the brain to communicate. It has been proposed that depression involves a paucity of those neurotransmitters. Dr. Krystal, with his colleague Dennis Charney, M.D., also a member of the BBRF Scientific Council and Dean of the Icahn School of Medicine at Mount Sinai in New York, found evidence otherwise.

“He led a series of studies showing that depleting the body of serotonin, or depleting the body of norepinephrine, or [both], did not produce depression in people,” Dr. Krystal explains. “This suggested to us that maybe the biology of depression and stress-related disorders didn't primarily live in the primitive parts of the brain that use serotonin or norepinephrine to communicate, but rather in the higher centers of the brain, the cerebral cortex, where glutamate is the predominant neurotransmitter.”

Both PTSD and depression can be caused by stress. Releasing cortisol is part of the stress response, our reaction to danger. "Cortisol can be harmful if it's too much for too long, but it may also be harmful if it's too little for too brief a period,” Dr. Krystal said. "In unipolar depression, we get a continual bath of cortisol, which is abnormal. In people with PTSD, not enough cortisol may have been released at moments of extreme stress."

The result may be a loss of connection-points between neurons, called synapses. Dr. Krystal found evidence of this loss in a pioneering MRI brain scan study of PTSD patients published in 1995. “Nowadays, using functional MRI, we can show that functional connections in the brain are reduced in PTSD in relation to or correlated with the overall severity of PTSD, and symptoms such as numbing and hyper arousal,” he said.

In both PTSD and depression, the brain evidently fails to remodel the lost connections. But over months of treatment with anti-depressants, brain scans show regrowth of dendritic spines—connection terminals and key players in the metabolism of glutamate.

Ketamine is thought by some to block the N-methyl-D-aspartate (NMDA) receptor, which binds glutamate. The temporary block may jolt the brain to release glutamate, prompting a cascade of regrowth and reorganization. For some people, a single dose of ketamine can make depression disappear for several days, or for as long as two weeks.

“There's no ketamine in the body at the time when people are reporting the greatest clinical benefit,” Dr. Krystal points out. "The benefit is an after-effect, not yet understood scientifically."

"Dissociation—feeling detached from one’s own body—and occasional nausea, two side-effects of ketamine, are easily managed in a clinic, and we have not had cases of drug abuse,”
Dr. Krystal said, referring to carefully controlled experimental use of ketamine in clinical settings. A many as three-quarters of severe depression patients who have tried ketamine infusions have found some relief. Over time, many need less frequent infusions: 40 percent of Yale’s patients come for infusions once a month or less often. The long-term effectiveness and impact of ketamine remain unproven.

“This new neurobiology of PTSD and depression suggests that there may be other mechanisms for treatment that may come from this line of research,” Dr. Krystal concluded. He hopes to have results from the PTSD trial by early 2020.

 
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How to use psychedelic mushrooms as a tool to heal C-PTSD

by Ashley Michaud | Sociedelic | Sep 13 2019

People exposed to severe and continuing violence, abuse, neglect, and suffering may develop complex PTSD, a condition that surpasses conventional PTSD.

I am Ashley, I have a Masters in Health Coaching and attuned as a Reiki Master / Teacher, I am also certified in Integrative Nutrition, Hormone Health and a published Author. I don’t mention this to give myself authority but instead show you what is possible when you use psychedelics as a tool for Elemental Growth.

I started my life off a mess – using sex, ecstasy, alcohol and cocaine to cover up pain rooted in childhood abuse. I was taught to hold things in and that the stuff I wanted to talk about didn’t matter. I was shown that drinking, putting on a mask and SAD (Standard American Diet) foods were my only options in life and then I had my first dose of psychedelic mushrooms. I realized just how f***ed up and oppressed every culture is, I saw the big picture. I moved out of my moms at 14 years old, was kicked out of high school shortly after and had a rough few years learning about the world and who I am.

At 20 I began experiencing hormonal issues but continued to party, at this time I also decided to get an education. Because I liked to party and travel, I enrolled into College as a Hospitality and Tourism student. Wise at the time but I am still paying student loans off for this party phase of my life. After a few semesters I began to travel Canada accumulating new life experiences along the way. One day as I looked out at the Pacific Ocean, I heard a voice tell me “it’s time to get sober, and to do this you have to go home to the roots of where your trauma started.”

I did get sober shortly after my return. I cleaned up my diet too and truly did start healing my roots. I created a timeline of my life, I said goodbye to friends, family, items and thoughts that did nothing good for me. I also threw myself into 2 hours of Kundalini Yoga DVD’s by Maya Fiennes everyday and a weekend dose of psychedelic mushrooms.

I was doing the meditation thing, the clean eating thing but it was mushrooms that truly made the connections and guided me back to purpose and passion for life. It was the mushrooms that told me to start looking at my food in a new light – to think about life force energy and what I consume psychically, mentally and spiritually – even more why I am consuming it. For a year I tested every food in my local grocery store and bulk bin to see if it would grow. That’s how I got into Fluoride, GMO’s and our solutions “Permaculture” and Integrative Nutrition.

It was mushrooms that introduced me and ultimately the reason I became obsessed with Joe Rogan, Duncan Trussell and the McKenna Brothers. It was mushrooms that supported my sacred journey to sobriety, backpacking 3 countries in South America with no map or clue what I was doing and it was mushrooms that has helped me clear out my C-PTSD so I can fill my life up with laughter and good times with my son who gets the best of me everyday.

What is a biohacking?

Biohacking is all about self-improvement and human optimization. As Tony Robins explains it “biohacking is essentially the practice of changing our chemistry and physiology through science and self-experimentation to energize and enhance the body.” Now I don’t know if Tony practices with entheogens, but I know that they have helped me make the process of biohacking more focused and enjoyable.

Here’s my prescription or C-PTSD

My biohacking specialty is Moon Cycles, Circadian Rhythm, Seasonal Alignment, Positive Psychology & personized Alchemy. Most recently I have been microdosing psilocybin, written about in my book Be The Change: Your Guide to Elemental Growth Through Nature, Love, Food & Movement.

Top 3 elemental tips:

- Write an ongoing list of all the things you hate and title it “Things I Will No Longer Tolerate”
- Take action by recognizing your feelings as they come up and then eliminating the things that make you feel like sh**
- Reward yourself with new habits that align with who and where you want to be. Your dreams are only possible when you believe “it’s all happening”.

I am Ashley, and this is my blog on how I biohacked C-PTSD and my destructive behaviors using psychedelic mushrooms. I am the girl that has cleaned up her life, broken through family karma and tapped into her natural flow. Like me you have everything you need to heal yourself and reach each dream you put forth but you don’t have to do it alone. Having your own guide on the side lines can help you breakthrough roadblocks and unleash your true potential.

As a health coach I don’t fix my clients, they do that, my job is to ask the questions that will spark transformation – so here it is: What resonated with you most? How do you think this bio-hack will be of service to you rising to become the hero of your own story? Sending you good vibes & positivity on your Elemental Growth journey, it’s all happening!!

 
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How MDMA is changing the treatment of PTSD*

by Rachael Beairsto | Psychiatry Advisor | October 7, 2019

Rick Doblin, PhD, founder of MAPS, anticipates that MDMA will be approved for PTSD by 2021. During his presentation at the 2019 Psych Congress, held October 3 to 6 in San Diego, California, Dr Doblin discussed results of recent research and future directions for treatment of PTSD.

Millions of Americans are affected by PTSD. Among veterans, it is the third most prevalent military service-related disability, which costs the Veterans Affairs disability payments service billions of dollars each year. Furthermore, treatment for PTSD can be challenging given the high number of nonresponders.

MDMA, a known psychoactive drug that is most often used recreationally, has been identified as potential therapeutic modality for this challenging condition. MDMA counters the neurologic effects of PTSD, which manifest as hypoactivity in both the hippocampus and prefrontal cortex and hyperactivity in the amygdala.

MDMA is not the entire therapy for PTSD; instead, it is MDMA-assisted psychotherapy — optimized with thorough preparation and integration of therapeutic outcomes — that has had early success in PTSD in multiple phase 2 trials and has now moved on to phase 3 studies.

In a series of 6 international phase 2 MAPS-sponsored studies, an active dose of MDMA (75-125 mg) was compared with a nonactive lower dose (0-40 mg; placebo group) in MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD over multiple integrative sessions.

At 2-month follow-up, more than half of patients who received the active MDMA dose no longer met the diagnostic criteria for PTSD (56 percent, vs 23 percent in the placebo group). This improvement in PTSD with an active dose of MDMA was even greater at 12-month follow-up: two-thirds of patients (68 percent) were categorized as no longer having PTSD, indicating prolonged healing after MDMA-assisted therapy.

On the day of administration, rates of anxiety, jaw clenching/tight jaw, lack of appetite, and nausea were higher in patients who received the active dose of MDMA, while fatigue and headache were more common in the comparator group. Despite concerns about longer-term neurotoxicity with MDMA, the investigators noted no neurocognitive changes after treatment.

On the basis of these data, the United States Food and Drug Administration (FDA) approved the trial to move to phase 3 and granted breakthrough designation for MDMA-assisted psychotherapy for PTSD in 2017. The European Medicines Agency also approved the study to move to phase 3, with the condition that migrants and refugees be included. An interim analysis of the first of the phase 3 studies is expected around March 2020.

Though costs for MDMA drug development are high — an estimated $34 million before FDA approval and $11 million related to European Medicines Agency approval — MAPS, a nonprofit organization, is refusing investment from pharmaceutical companies in an effort to avoid competing interests. Representatives from MAPS are in conversations with the FDA to discuss expanded access through compassionate use, given that there are millions of patients with PTSD and only hundreds currently being enrolled in clinical trials.

As for next steps, Dr Doblin explained that patients with PTSD have a desperate need for this therapy. While MDMA-assisted treatment will never be a take-home, self-administered cure, he envisions a future with highly trained therapists at thousands of accessible psychedelic treatment centers across the world.

*From the article here:

 
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To unravel PTSD, she took MDMA*

by Will Stone | Apr 22 2019

Lori Tipton had recounted the details of her mother’s death many times, always with the same detachment as that first 911 call.

“I was the one who discovered their bodies in her home,” Tipton says of that night in 2005. “I completely just disassociated. … I couldn’t believe what I was seeing.”

A murder-suicide, her mother had killed a lover and a close family friend.

It wasn’t Tipton’s first encounter with trauma.

When Tipton was 20 years old, her brother came to visit her in New Orleans for his 21st birthday. He died of an overdose that night in her home.

“In the wake of that experience, I didn’t really allow myself to process any of that, because I immediately began to take care of my mother,” Tipton, now 39 years old, remembered.

Her mother had struggled with mental illness for many years and took a sharp decline after her son’s death.

But Tipton’s diagnosis of post-traumatic stress disorder didn’t come until later, and only by accident when Hurricane Katrina hit.

She was displaced and spent weeks in and out of hotels. Her life felt like a steady stream of loss — the tragedy only compounded by the devastation of the storm and its aftermath.

“Nearly everybody returning to New Orleans was being diagnosed with PTSD,” Tipton said. “I think that partly led me to believe that, maybe, I didn’t have this affliction.”

He describes the years that followed as “seeing the world through dirty goggles.”

“Imagine your brain, you go down a road and to the left is like happiness and joy, and to the right — anxiety,”
she said. “No matter what the circumstances were in my life, my brain would always go right, every single time.”

What happened to Tipton the following year cemented the sense that she was somehow broken, “unable to be saved,” as she describes it.

A close friend of Tipton’s, someone she trusted, raped her.

“I ended up pregnant from that rape and had an abortion,” she said.

Tipton avoided talking about the assault. She says she tried to mask her fear and isolation.

Heart-pounding panic attacks and unexplained dread became a daily part of her life. A specific word or touch, even from someone she loved, could overwhelm her with fear.

“When you have PTSD, you are living in this constantly triggered environment,” she said. “My disorder had become so much a part of who I was.”

She felt as if the universe was punishing her.

“Anytime I felt I could trust myself, I was proven wrong,” she said.

For more than a decade, Tipton searched for a remedy.

She tried everything offered — or that she could think of — to mitigate the symptoms of PTSD: antidepressants, psychotherapy, acupuncture, meditation and hypnotherapy.

She became a yoga teacher, tried Rolfing (a type of deep-tissue massage) and even saw a witch doctor.

Nothing really worked.

Amid a renaissance in psychedelic research, new treatments emerge

In 2017, Tipton came across an online ad for something different: researchers from the Multidisciplinary Association for Psychedelic Studies, also called “MAPS,” were looking for people with chronic, treatment-resistant PTSD.

It was an opportunity to participate in Phase 2 clinical trials for an experimental, yet promising model of treatment: MDMA-assisted psychotherapy.

Tipton was unsure at first.

“I went in there being as open as possible, but with a great deal of skepticism,” she said.

First synthesized in the early 1900s, MDMA is a psychoactive drug that boosts neurotransmitters like serotonin and also dials down activity in the amygdala, a part of the brain that processes fear. It can increase empathy and social connection.

The therapeutic benefits were explored throughout the 1970s, including in contexts like couples therapy. But those efforts stalled when the federal government — alarmed by the rise of the club drug “Ecstasy,” which can contain MDMA — classified it as a Schedule 1 drug in 1985.

Now research into psychedelics has picked up again in the U.S and that is offering hope for treating a variety of mental illnesses — from substance use disorder to depression.

MDMA is on the front line of these emerging treatments. A new drug hasn’t come onto the market to treat PTSD in more than a decade.

In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to MDMA-assisted psychotherapy, developed by MAPS.

According to the FDA, the designation is reserved for a drug with preliminary clinical evidence indicating that it “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”

Phase 3 trials are taking place across the country, as well as in Canada and Israel.

“Seeing what was possible, you can’t go back,” said psychotherapist Saj Razvi of sessions aided by MDMA. “Things that may take months or even years to accomplish, or may never get accomplished, we see people are able to work into that territory.”

Razvi is director of medical education at Innate Path, a clinic based in Colorado. He was also clinical investigator in the Phase 2 trials for treatment-resistant PTSD.

“MDMA allows you to contact feelings and sensations in a much more direct way,” Razvi said.

The MAPS protocol typically consists of two to three sessions when MDMA is administered, each eight hours long. Those are bookended by sessions of therapy to integrate what the person has discovered while under the influence of MDMA.

Razvi, who has observed hundreds of hours of these sessions, says only by returning to the origin of the trauma can you “unpack this material, feel your way through it and get to the other side.”

“These are fundamentally powerful experiences that are corrective in nature, going back to these places where we were crushed,” he said.

It can look painful, he says — what some might call “a bad trip” — but only through this process can the quality of these traumatic experiences change.

“When we are being traumatized, we are fundamentally alone,” he said. “One of the things that MDMA does is, really, lets you know that you are not alone.”

Trauma revisited in the embrace of MDMA

Lori Tipton knew the story of her mother’s death well, but it always felt like it was happening to someone else.

That changed while on MDMA.

“I was able to remember all of those things, like truly able to remember these little pieces that were missing before,” she said.

She could stay present in the most terrifying moment of her life, safe in the “loving embrace of MDMA.”

As those memories emerged, they formed something new — forgiveness.

“I was able to find such empathy for myself. I realized how much I was thinking this was my fault and I should have done something,” she said.

Then she told herself to let it go.

“This is a terrible thing that happened, but you carrying the fear and shame over this, it’s worthless.”

Tipton unearthed other memories, too, feelings of joy and peace that had been sealed away. She was playing in the snow with her brother when they were children.

“I could remember exactly how I felt, that excitement of the first snow,” she said.

But as her last session was coming to an end, one moment still remained out of reach: her rape.

When she spoke of it, the heaviness would return. There was no catharsis.

Her therapists, a male-female duo, suggested something.

“How would you feel about potentially going into one of these poses and seeing what happens?”

Years of practicing yoga, even teaching it, and certain poses Tipton could never do; it took her back to the assault.

She lay on the floor and took the pose, her legs draped over her shoulders.

As the panic surfaced, they offered her a simple question.

“Can you ask what that feeling needs?”

“It needs to be heard,”
Tipton replied without thinking. “I had felt so silenced for so many years, people didn’t believe me … that, I needed that moment for them to understand me.”

They stayed with her, crouched on the floor, and let her know they did believe her.

“It was the first time I had told that story and that had been the response,” she said.

That was the end of Tipton’s treatment with MDMA.

More than a year later, she no longer fits the diagnostic criteria for PTSD. That was the case for nearly 70 percent of those who were given MDMA in the Phase 2 trials. It was a small group, fewer than 100.

Still, the potential of achieving durable remission could be a paradigm shift for millions with PTSD.

Tipton says it saved her life.

“Everything is at my fingertips for me in a way that it never was before,” she said. “I want that for everybody.”

*From the article here:

 
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