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Medicine PTSD

mr peabody

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MDMA-assisted psychotherapy for PTSD

Posttraumatic stress disorder (PTSD) is a disorder that describes the issues faced by many people after they experience or witness a traumatic event. Anyone who has been exposed to traumatic events that causes a serious fear for their life or the lives of others is at risk to develop PTSD. People typically affected include: survivors of violent acts and disasters, emergency responders to traumatic events, people who experience the sudden death of a loved one, anyone who has been abused, neglected children, and combat veterans. However, many other events can be traumatic as well, particularly to people of color, including police harassment, distressing childbirth experiences, and incarceration.

MAPS is a non-profit research and educational organization that is currently sponsoring Phase 3 clinical trials of MDMA as a tool to assist psychotherapy for severe PTSD. Importantly, MDMA used in these trials is not the same as the street substances known as "ecstasy" or "molly," since these drugs frequently also contain unknown and/or dangerous adulterants. In MDMA-assisted psychotherapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for several years. More information on MDMA can be found in the MAPS Investigator Brochure, which is available online here.

Preliminary studies suggest that MDMA can catalyze powerful psychotherapeutic work in helping people overcome PTSD by reducing fear of traumatic memories and increasing feelings of trust and compassion towards others without causing sensory distortions or inhibiting access to difficult emotions. As such, MDMA could increase the effectiveness of psychotherapy by strengthening the alliance between therapist and patient.

In our site at the University of Connecticut, we are participating in a MAPS-sponsored, FDA reviewed Phase 2 open-label study and then moving on to Phase 3 randomized clinical trials in Spring 2018. We are focusing on the recruitment of ethnoracial minority participants who meet criteria for PTSD. Our team’s work is focused on culturally-sensitive and respectful treatment approaches for people of diverse backgrounds.

We recognize that doing things the way they have always been done will not be sufficient to open the doors of these therapies to people of color. A culturally-informed approach must be used. Here are some of the efforts that have been made to date to ensure the ongoing MDMA research is culturally inclusive:

- Addition of a study site focused on the ethnic minority trauma experience
- Revision of informed consent documents for all sites to improve understanding and acceptability to people of color
- Diversification of the UConn treatment team at every level
- Ongoing cultural training for all UConn team members, with an emphasis on cultural humility
- Re-examination and revision of the setting and music used during MDMA sessions for cultural congruence
- Recognition and validation of experiences of racial oppression at a cultural and individual level
- Integration and specialized training for independent rater pool, with ongoing supervision for cultural differences

http://www.mentalhealthdisparities.org/mdma-trauma-study.php
 

mr peabody

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Bob Walker has suffered from PTSD for over 30 years. He's not alone in this struggle,
but he claims to have found a way out, through MDMA therapy. A group of specialists
across the country are using it to heal trauma victims in ways previously unimaginable.



Ecstatic states

by Lessley Anderson

Can an illegal drug heal crushing trauma?

In the Vietnam War, Bob Walker was a helicopter mechanic who saw his best friend decapitated by an incoming helicopter’s propeller blade. Ever since then the 69-year-old Paradise, CA vet has struggled with PTSD — a psychological condition that afflicts 7–8 percent of the population. It hits people who have been exposed to highly stressful situations in which their “fight or flight” response has been activated. Rape survivors. War veterans. Policemen.

People with PTSD can be highly irritable and suffer from insomnia, nightmares, and the inability to sustain deep relationships. Or, like Walker, they can walk through life feeling eternally numb. “Over the years, I tried everything from prescription drugs to biofeedback,” says Walker. “But nothing really worked. I knew something just wasn’t right.”

Then one day three years ago, Walker saw a segment on CNN about an experimental drug trial going on in South Carolina to treat people suffering from PTSD. In the study, patients took MDMA, more commonly known by its street name ecstasy, in the company of psychotherapists. The drug’s famous warm-and-fuzzy ability to enhance a person’s well-being and create a surplus of empathy allowed many of the participants to revisit painful memories without their usual fear. In neurochemical terms, MDMA decreases the fear response in the amygdala. It also stimulates the release of the feel-good neurotransmitter serotonin, as well as oxytocin and prolactin, which cause feelings of love and bonding. After taking the drug, many patients could look at their lives in a new way, reprocess trauma, and rewire their own brains.

"I got it, right away," says Walker, about watching the segment detailing the experiments. He figured, living right next to a college town, he could ostensibly score drugs easily. Why not try it himself?

"Finding MDMA was harder than I expected," he said. Asking around and attending a psychedelics event got him connected to some people doing sweat lodge and peyote ceremonies, but no ecstasy. But he finally tracked down ecstasy through a friend of a friend’s son and contacted a former therapist, who agreed to work with him while he was high. Jennifer*, who asked that her real name not be used because she feared she could lose her license, was a self-described "conservative" single mom who was typically scared of drugs. But she felt a warmth for Walker and trusted him. "For some reason, it didn’t feel wrong," she said. "He had really done his research." The first time was a therapy session like no other. "He didn’t seem high, he just seemed ‘real,’" she said. "We were able to carry on an intimate conversation for the first time."

"You lose your sense of connection,"
says Walker, describing the feeling of having PTSD. But on MDMA, Walker felt deeply connected, not just to his therapist, but also to himself, something he’d long struggled with.

The drug trials that inspired Walker were the work of MAPS, a nonprofit research organization whose name stands for Multidisciplinary Association for Psychedelic Studies. It’s one of a small handful of organizations worldwide trying to establish scientific evidence that psychedelic drugs have therapeutic value.

In the study looking at how MDMA could treat PTSD, the drug was given in conjunction with talk therapy. Patients lay down in a therapist's office and listened to soothing music with headphones, wearing eyeshades. They had the option of talking about what they were experiencing, and received counseling before and afterwards to integrate what happened to them while on the drug into their everyday lives. According to MAPS, 83 percent of the 19 people treated in a recent group had breakthroughs in this MDMA-assisted therapy and showed significant improvement in their PTSD symptoms.

"The MDMA allowed me to be my very, very, very best self, and I got to take care of my most broken self with my best self," says Rachel Hope, a sexual-abuse survivor who participated in the study. MAPS’ results from this study were encouraging enough to the FDA that it was able to expand its efforts into what’s known in drug-trial parlance as "Phase 2 studies." It’s now doing the same study with four new groups of patients in South Carolina, Colorado, Israel, and Vancouver.

In addition to the MDMA-to-treat-PTSD study, MAPS has also studied how LSD can help soothe anxiety in people with terminal illnesses, and in March received approval to study the effects of marijuana to alleviate PTSD. The latter study will be one of only two government-approved medical marijuana trials ever conducted.

Similarly to MAPS, the Santa Fe-based scientific research group the Heffter Research Institute has been collaborating with scientists at UCLA, Johns Hopkins, and NYU to study the therapeutic applications for psilocybin, the active ingredient in hallucinogenic mushrooms. In one study, published in 2011, it investigated how the drug might be used to make terminally ill cancer patients feel less anxious and depressed, and reported that of 11 patients given the drug, 30 percent reported an elevated mood that lasted long after the drug wore off. Now, Heffter scientists are looking at how psilocybin might help cure alcoholism and get people to quit smoking.

In many ways, this research isn’t new. Besides the thousands of years of indigenous peoples’ ritual use of mind-altering plants like ayahuasca and peyote, there was some modern scientific exploration of these kinds of substances, too. Before it was criminalized in 1968, LSD was being used by some doctors as an experimental method for treating alcoholism and anxiety. MDMA, prior to being outlawed in 1985, was used by hundreds of psychotherapists in the United States to treat a variety of phobias, addiction, trauma, and even relationship problems. In an interview with psychiatrist Julie Holland, author of the book Ecstasy: The Complete Guide, one of these therapists recalled: "When it came to, for instance, couples therapy, it was a remarkable catalyst."

Hopes for relief

MAPS and the Heffter Research Institute were founded with the mission of reintroducing these types of investigations and documenting their results in peer-reviewed journals. MAPS opened in 1986 and Heffter in 1993, after LSD, MDMA, and psilocybin became illegal. But until the 2000s this type of research would have been virtually impossible. The National Institute on Drug Abuse and negative media coverage throughout the ’80s and most of the ’90s depicted drugs like ecstasy, pot, and acid as a scourge without any therapeutic value. (This was the era of the infamous PSA: "This is your brain on drugs!") These drugs are all, in fact, categorized as "Schedule 1" by the Controlled Substances Act along with quaaludes and heroin, and are defined as having "high potential for abuse and dependence" and "no currently accepted medical use." But personnel changes in the FDA and a softening of attitudes within the DEA and Institutional Review Boards, both of which greenlight drug trials, have opened up the field of psychedelic research like never before.

"A lot of the demonization of drugs as evil in all walks of American life has really calmed down," says Jeffrey A. Fagan, professor of law at Columbia University. "And that’s a great thing. There’s no reason why we can’t think in careful and responsible steps about the therapeutic value of controlled substances." As scientific evidence begins to mount, psychedelic researchers are looking towards a day when drugs like ecstasy, pot, LSD, and psilocybin will be categorized as "Schedule 2" drugs — that is, drugs that have risks associated with them, like Ritalin or Oxycontin, but can be prescribed by a doctor.

Rick Doblin, the founder of MAPS, says he envisions a future when hospice centers for the terminally ill sit next to psychedelic therapy centers, and licensed doctors can prescribe MDMA in clinics similar to the way methadone is handled. "Things are lining up in our culture and we have the opportunity to reintegrate psychedelics," says Doblin. "They’ll have an honored place rather than a suppressed place."

Harsh realities

But it may be too early for Doblin and his colleagues to get too excited. By the FDA’s own reporting, only 5 percent of all investigational new drugs actually make it through the testing and approval process. If any of the drugs that MAPS and the Heffter Research Institute are studying ultimately get approved for therapeutic use, the organizations’ research will have to show positive results among hundreds of participants.

Conducting these larger "Phase 3" studies will cost millions of dollars. Unlike commercial pharmaceutical companies with deep pockets, MAPS and the Heffter Research Institute are privately funded, acting, essentially, as nonprofit pharmaceutical companies. The drugs they’re studying have patents that have expired, making them of little interest to Big Pharma. Anybody could ostensibly make generic versions of them, driving down price and potential earnings.

Raising millions more from the public to continue this research won’t be easy, particularly because at least in the case of the Heffter Institute, psychedelic research operated under the radar for years. Dr. David E. Nichols, president and co-founder of the Heffter Research Institute says that his organization tried to keep its work on the down-low because it was widely considered controversial. Take the research around psilocybin and people with terminal illnesses, for example: "There are a lot of taboos about how people die," says Nichols. But when Nichols describes the effects the drug can have on people dying of cancer, he presents a moving case that would be hard for anybody to ignore.

"We had one woman say, ‘I realized how precious the people are around me — and I want to enjoy them while I still have time here,’" says Nichols, referring to a cancer patient who took psilocybin in his study and is now deceased. "She said that it changed her completely, and she was able to embrace the life she had left, and it should be there as an option for people to do if they want."

Nichols believes that, culturally, we’re getting closer to that reality. "Young people are more accepting of things formerly viewed as social ills, like same-sex marriage and certain illegal drugs," he says.

"The people who thought psychedelics were dangerous drugs are getting old and dying off," says Nichols. "It may be that when future generations approach that time of life, they’ll do so with an open mind, and regulations may follow."

 
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