[Article] Ecstasy to treat stress disorder - 27/2/04

Ecstasy to treat stress disorder
From Elaine Monaghan in Washington
27 Feb 2004


ECSTASY, the drug blamed for rave deaths among teenagers, is being put to more respectable use in the United States by a psychiatrist who believes that it can cure the crippling effects of post-traumatic stress disorder.

US drug authorities gave Michael Mithoefer permission this week to use MDMA, or Ecstasy, in a study of 20 patients suffering from the disorder, which sends victims into a debilitating panic as they repeatedly relive a past trauma.

“There is enough suggestive evidence to warrant further study,” said Dr Mithoefer, who will lead the research at the Medical University of South Carolina. He built his case on evidence gathered before Ecstasy was banned in 1985, including instances where rape victims reported relief from their symptoms in controlled therapy enhanced by the drug.

Rick Doblin, president of a non-profit psychedelic studies group that is sponsoring the study, has worked with one such woman who also became an advocate for MDMA’s use in therapy. Her rapist almost killed her. She had lost her ability to differentiate between past and present, Mr Doblin said. Sufferers of the disease “have this feeling that the trauma is about to happen again and they cannot go to certain places”, he added.

In a supervised therapy session using Ecstasy, the woman reported experiencing a kind of catharsis, where she was able to confront her trauma for the first time, he said.

Dr Mithoefer said that he was anxious not to create the impression that recreational Ecstasy use was safe. “I am concerned about people misinterpreting this,” he said. “I think it is very important that people understand the difference between safe use in this kind of controlled setting and unsafe use in settings such as raves, which can be dangerous.”

Mr Doblin, 50, is not shy about admitting to his own Ecstasy use, which he says has helped him in his relationships and life in general. He believes that the drug should be legalised so that people can make their own informed decision.

L:ink

^^ Been a bit long in coming, but thankfully it will now be possible to legally demonstrate the effectiveness of MDMA in therapy for PTSD.

Yay to Rick and others of the Drug Reform Coalition. A lot of hard work has been put in by these people

Great! Let's hope that Dr Mithoefer does a good job, and provides even more solid circumstantial evidence for MDMA being a useful therapeutic tool.

Ta haste

haste said:

Dr Mithoefer said that he was anxious not to create the impression that recreational Ecstasy use was safe. “I am concerned about people misinterpreting this,” he said. “I think it is very important that people understand the difference between safe use in this kind of controlled setting and unsafe use in settings such as raves, which can be dangerous.”

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I like this paragraph... One one hand I can imagine stupid ignorant people seeing MDMA's use in research and completely writing it off as a perfectly safe substance, while on the other hand he say's its use "in settings such as raves, which can be dangerous". He's showing both sides of the fence, but in a way sitting in the middle without bias.

Or maybe I read that completely wrong.

Well I think his reasoning lies in 2 main areas;

Firstly, relatively high doses are recommended for a clinical setting. In this environment, there are no loud or disturbing noises although patients are usually offered some relaxing music of their choice through headphones. This comfortable setting sees the patient lying down with minimal light and loud noise and enables the subject to recount without fear, thus optimising the session.

Secondly, for the treatment to be most effective, it's considered important that patients be "MDMA virgins". Someone who has managed to skirt his/her surfacing problems when first using MDMA rather than facing them, may not respond at all to this therapy aid. It's also been found that when MDMA is first used in this environment, very few successfully treated patients go on to use the drug in a recreational setting.

Always good to see that research is being done though. Especially in countries such as the US, they are showing they are willing to see if there are benefits to the community through controlled use.

Very positive...

I would get up and bust out to my heart monitor

This is excellent news. I suspect that MDMA would also be a valuable tool for assisting therapy for people with Borderline Personality Disorder. The best treatment for BPD is long term intensive therapy, but the nature of BPD makes it very difficult for the individual to follow through with therapy.

all i can do is smile from reading that.

I think its so important that the positives of MDMA be recognised and researched. Finally some truth spoken out about it.

Mr Doblin, 50, is not shy about admitting to his own Ecstasy use, which he says has helped him in his relationships and life in general. He believes that the drug should be legalised so that people can make their own informed decision.

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You would have to say he is sitting a little bit left of centre, go Mr Doblin.

And you would have to suggest it might be a bit of fun to go to a "non-profit psychedelic studies group" meeting

Orignally Posted by: planet dweller
And you would have to suggest it might be a bit of fun to go to a "non-profit psychedelic studies group" meeting

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Count me in on that, i think a studie group is just what we need..

I bet he had his own magical experience his first time, which led him to his liberally righteous cause

For those interested a few more articles....

DEA Accedes to Ecstasy Test

After a monumental struggle by a small group of advocates who believe Ecstasy, or MDMA, can have beneficial health effects, the Drug Enforcement Agency has finally given the go-ahead to test the drug on patients with post-traumatic stress disorder.

If Ecstasy proves to be an effective and safe treatment for post-traumatic stress disorder, therapists can sign legal prescriptions for the drug. The DEA gave researchers permission to test the drug on Feb. 24, according to the Multidisciplinary Association for Psychedelic Studies website, the organization funding the MDMA research. The first phase of the trial will include 20 trauma victims -- 12 will receive MDMA and 8 a placebo.

Michael Mithoefer, a psychiatrist with a private practice in Charleston, South Carolina, had been working with Rick Doblin, the founder and president of MAPS for nearly four years to get the trial approved. In association with MAPS, Doblin has been trying to get MDMA clinical trials approved since even before the drug was oulawed.

"It's been 20 years," Doblin said. "We started trying to get research approved by the FDA as soon as the DEA moved to do make it illegal (in 1984)."

Ecstasy is known as a party drug, but before MDMA was outlawed in 1985, therapists were already using it to help patients better cope with life's travails. When the DEA named MDMA a schedule 1 drug, meaning it has no known medical use and a high potential for abuse, some therapists continued their work in underground clinics.

Therapists as well as casual users have long believed that Ecstasy can help people suffering from post-traumatic stress and other psychological problems because the drug creates feelings of euphoria, warmth and empathy. Most say that combining the drug with therapy is key to helping patients learn to incorporate what they experience on the drug into their everyday lives.

"Many clinicians have suspected for a long time, and therapists have a lot of anecdotal information that MDMA has the potential to be very healing for people with a number of disorders including PTSD," said Michael Klein, a psychologist with a private practice in San Francisco.

Following some preliminary MAPS-funded trials that showed MDMA would be safe for therapy, the FDA approved the trial in 2001. But several more hurdles remained. An independent review board had to approve the design of the trial, and since Ecstasy is a schedule 1 drug, in the same category as LSD and heroin, the DEA also had to give its stamp of approval.

In the new trial, study volunteers will receive two 125 milligram doses of pure 3,4-methylenedioxymethamphetamine (MDMA) synthesized by a chemist at Purdue University. A control group will receive a placebo. Patients will take the medication on two separate occasions spaced three to five weeks apart, combined with talk therapy sessions. Patients will stay overnight at an unidentified clinic when they receive the drug.

Mithoefer said he had been expecting the DEA's decision any day, because he knew the study fulfilled all of the agency's requirements.

"If there's an FDA approved study, the DEA can only deny the license if there's something like a felony, a drug conviction or some reason to think there would be diversion of the MDMA," Mithoefer said. He also has a safe bolted to the floor in his office, as well as an alarm system, to help ensure the drug does not fall into the wrong hands.

In September 2002, the MAPS effort hit a speed bump when a longtime opponent of Ecstasy, George Ricaurte, published alarming data, the first to show that MDMA damaged dopamine neurons. But almost exactly a year later, Ricaurte retracted the study because he discovered he had mistakenly used a different drug, methamphetamine, instead of Ecstasy, in the trial.

Ricaurte and his wife, Una McCann, have published much of the data used by the National Institute on Drug Abuse to warn people about the dangers of Ecstasy. But even Ricaurte and McCann say if the study is properly designed and controlled, they don't have a problem with it. The key issue, they said, is that the patients know the risks associated with the drug as well as the likelihood that they might benefit from it.

"These include (but are not limited to) adverse events related to the acute pharmacological effects of MDMA and the potential for brain serotonin neurotoxicity," Ricaurte said. "If subjects are fully informed of these risks and still chose to participate, and if the protocol has been deemed scientifically and ethically acceptable by the appropriate regulatory bodies, then it should be held to the same standards as other clinical research projects."

Rick Doblin, director and founder of MAPS has said he believes Ricaurte's research is politically motivated, and the retraction is evidence that all of his research should be reevaluated.

Link

DEA Approves Trial Use Of Ecstasy in Trauma Cases

washingtonpost.com - March 02, 2004

Capping a 17-year effort by a small but committed group of activists, the federal Drug Enforcement Administration has agreed to let a South Carolina physician treat 12 trauma victims with the illegal street drug ecstasy in what will be the first U.S.-approved study of the recreational drug's therapeutic potential.

The DEA's move marks a historic turn for a drug that has long been both venerated and vilified.

Ecstasy, also known as MDMA, is popular among casual drug users for its reputed capacity to engender feelings of love, trust and compassion. The government classifies it with LSD and heroin as a drug with no known medical use and high potential for abuse.

Although the study's approval is by no means a federal endorsement of uncontrolled use, it will give ecstasy's proponents their first legitimate opportunity to prove the drug can offer medical benefits.

"MDMA opens the doorway for people to feel deep feelings of love and empathy, which is the core of being human," said Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies in Sarasota, Fla., the nonprofit research and educational organization funding the trauma study. "We should be looking at that and learning from that."

As a result of the DEA action, sometime in the next few weeks the study's first participant -- still to be selected -- will check in for an overnight stay at an outpatient counseling center in the Charleston area. (Investigators have asked that the location not be precisely identified). He or she will take 125 milligrams of 99.87 percent pure 3,4-methylenedioxymethamphetamine -- probably the highest quality MDMA on Earth -- synthesized by a Purdue University chemist.

Michael Mithoefer, the Charleston psychiatrist who will lead the research, emphasized that ecstasy is by no means a benign drug. Indeed, he said, on occasion it has proved deadly at all-night dance parties, or raves, where it is often consumed.

"The fact that we have good evidence that we can use MDMA safely in a controlled setting does not mean it is safe to take ecstasy at a rave," Mithoefer said.

The goal is to help people with debilitating post-traumatic stress disorder face the pain at the core of their illness, he said, and learn to work with it.

"Because of MDMA's reported ability to decrease levels of fear and defensiveness and increase the sense of trust, we hope that will be a catalyst for the therapeutic process," Mithoefer said.

Advocates have been aiming for such a study since 1986. The Food and Drug Administration gave its blessing in November 2001 after long consideration and analysis of three human safety studies funded by Doblin's group. It was two more years before the study got the required approval of an independent science and ethics board.

The DEA's issuance last week of a Schedule 1 registration, which allows Mithoefer to administer the drug under the specific conditions of the study, was the last hurdle.

From all indications, it was not a decision made lovingly by an agency that has called ecstasy "one of the most significant emerging drug threats facing America's youth." But with all the other federal requirements met, the role of the DEA -- whose responsibility is to prevent "diversions" of the drug -- was limited to documenting that Mithoefer had a big enough safe bolted securely enough to the floor, a qualifying alarm system and a set of records that would ensure careful tracking of every speck of the stuff.

"Whether we agree with the study is not relevant," said Bill Grant, the spokesman for the DEA. "All the qualifications were met."

Even some of ecstasy's leading critics said they could abide by the study if regulators were satisfied.

"The key issue is that all potential subjects be fully informed of the risks," George Ricaurte, a professor of neurology at Johns Hopkins University who has studied the drug, wrote in an e-mail.

Ecstasy was popular more than 20 years ago as an aid to psychotherapy. Recreational abuse drew it to the attention of the DEA, which in the mid-1980s began regulating it.

A black market emerged, and millions of young ravers and others have since tried the substance, which can induce what enthusiasts describe as up to eight hours of empathic conversation, contemplation and energetic sociality.

Most users report no long-term negative effects, though some speak of fatigue or depression for a few days afterward. There is a heated scientific debate as to whether ecstasy causes significant, long-term damage to parts of the brain.

All experts agree that ecstasy on rare occasions causes a sudden, inexplicable and fatal form of heat exhaustion. That is one reason there will be an emergency room doctor and nurse outside the Charleston-area therapy room -- where each patient will sit and talk for hours with Mithoefer and his wife, psychiatric nurse Annie Mithoefer.

To be chosen for the study, the patients -- all victims of assaults unrelated to combat -- must have moderate to severe post-traumatic stress disorder unresponsive to other drugs and therapies, and will first engage in preliminary therapy sessions with the Mithoefers. Twelve participants will get the drug, and eight will get a placebo. Each will spend that first session talking, listening to music and lying on a couch as needed -- though study rules require that at a certain point each patient must engage in a discussion about the trauma that has left him or her debilitated.

Periodic physical, emotional and neurological checkups will continue for several weeks, followed by a second ecstasy session.

Marcela Ot'alora, who in 1984 -- before ecstasy's use was criminalized -- took it under a therapist's supervision to help her deal with the aftereffects of being raped, lauded the Charleston study's approval.

For years, she had been unable to wait in lines or stand with her back to crowds because of a fear of being attacked, said Ot'alora, who today is a therapist in a western state that she asked not be revealed.

Ecstasy had a profound effect, she said: "I think for the first time in my life I was able to have compassion for myself, and also felt I was strong enough to face something that was frightening without falling apart.

"It's not a miracle drug, by any means," she continued. "But it allows you to go into the trauma and know it is past, and separate it from the present."

She said she has not wanted to take the drug again, even though she still feels less than fully healed.

"It's almost like it showed me the path I needed to take," she said, "and I can do that on my own now."

For more news, or to subscribe to the newspaper, please visit http://www.washingtonpost.com

Link

Marcela Ot'alora, who in 1984 -- before ecstasy's use was criminalized -- took it under a therapist's supervision to help her deal with the aftereffects of being raped, lauded the Charleston study's approval.

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I'm always mentioning the conference in 2001 when Marcela spoke along side Doblin, The Sulgins and many others. Because the original recordings were in real player, and my D/L speed was 28bps, I had to record to external tape, reload to H/D and edit out the gaps. It was a good 3 full days work from start to finish. Seeing that these recordings are no longer available online, I'm considering converting these wav files to mpeg and hosting them. At present the total size of the spoken conference is ~35 Meg. However, I'll email Ethan Nadelman first as I wouldn't to step on the toes of any group with the power to force the DEA into saying yes to MDMA

^^ The only part I didn't bother converting was the final talk given by representatives of the Rave scene. Anxiously awaiting this when first listening to the conference, I was disappointed to say the least. It was the only thing which detracted from the otherwise excellent topics. Sad really, but it almost felt there was no place for the "Rave Cause" at this gathering.
However, nothing was brought up that hasn't been discussed here many times.

The only other major flaw is the quality of the audio itself, made worse from using an analogue format during conversion. To be fair to the well intended Ravers, the audio was a large part of the dismal presentation on their part.

I should stress that this is really compelling listening. Like any conference incorporating those experienced in public speaking with those who are not, some speakers are bad speakers so the audio is more noticeable. But whether you're a user or a concerned mum or dad, this will keep your attention and fill you with emotion. Have a Mum, Dad, Uncle etc. who doesn't know about or understand why people use MDMA? Have them listen to this, pointing out of course the mistakes in Ricaurtes work which surfaced late last year.

For such a great event, instrumental in bringing together the common goal of many diverse groups - to approve MDMA for PTSD therapy - this event should be recognised as an almost historic event. From it stemmed "The Drug Policy Alliance"

Wait till you hear the questions fired at Ricaurte by Doblin.

So are you [anyone] interested if it was in smaller pieces?

[Edit: spelling and grammar corrections again, not to mention an unfinished sentence. Come on AI researchers, I need a good speak-type prog p_d]

Absolutely... It would be great if it was available in small packets so we with the slow net connections could listen to sections at a time.

phase_dancer - definately interestred!