MDMA for PTSD

Results are in, and they’re pretty spectacular.

The first published results for MDMA-assisted therapy in the treatment of Post-Traumatic Stress disorder are now in, and they’re eye-opening.

It’s only a 20-patient pilot study, and MDMA functions as an adjunct to therapy, not as a pure phamacological agent such as an SSRI or an anti-psychotic, raising the question about whether the results would generalize to other therapists.

Still, in a patient group with a median of 19 years of treatment-refractory post-traumatic stress disorder, getting 10 out of 12 of them to the point where they no longer meet diagnostic criteria constitutes an unprecedented success rate. Given the PTSD burden from Iraq and Afghanistan, this research – long blocked due to prejudice against MDMA (the active agent in street “ecstasy”) – now deserves a move to the front burner. It shouldn’t need to rely on private contributions, and it should be free of petty bureaucratic harassment and foot-dragging.

It should also be free of the hypervigilance of Institutional Review Boards. The notion that someone needs to be in a hospital for 24 hours after a single controlled dose of MDMA is flat-out absurd. And there’s simply no evidence of neurotoxic effects at the dosages and frequencies involved.

Author: Mark Kleiman

Professor of Public Policy at the NYU Marron Institute for Urban Management and editor of the Journal of Drug Policy Analysis. Teaches about the methods of policy analysis about drug abuse control and crime control policy, working out the implications of two principles: that swift and certain sanctions don't have to be severe to be effective, and that well-designed threats usually don't have to be carried out. Books: Drugs and Drug Policy: What Everyone Needs to Know (with Jonathan Caulkins and Angela Hawken) When Brute Force Fails: How to Have Less Crime and Less Punishment (Princeton, 2009; named one of the "books of the year" by The Economist Against Excess: Drug Policy for Results (Basic, 1993) Marijuana: Costs of Abuse, Costs of Control (Greenwood, 1989) UCLA Homepage Curriculum Vitae Contact: Markarkleiman-at-gmail.com

9 thoughts on “MDMA for PTSD”

  1. Having had the experience of real MDMA (not street stuff) several times before and around the time it was made Schedule I, I'm not surprised at these results. My experiences were on vacation (usually in the mountains and usually with friends) and not in a therapeutic or laboratory setting, so this is all anecdotal, but MDMA had the ability to get me to ignore whatever stress was bothering me at the time, and allow me to relate to people without barriers. I wouldn't be at all surprised if MDMA is a useful adjunct to therapy for PTSD.

  2. Thanks to daksya for posting the full article.

    Someone help me out here. Table 2 of the full article gives the patient characteristics. The mean duration of PTSD is 248 months, or more than 20 years, but the study protocol (http://www.clinicaltrials.gov/ct2/show/study/NCT00090064?term=NCT00090064&rank=1&show_desc=Y#desc) says "Diagnosed with PTSD as a result of crime victimization or as a result of combat if symptoms have lasted for no longer than five years." It appears that the inclusion criteria changed after the study was designed. Perhaps the study was originally designed to evaluate MDMA for PTSD of relatively short duration.

    The flow chart in Figure 1 shows that 134 potential patients were assessed, and that 112 were excluded, 61 of them for not meeting inclusion criteria on the telephone screen. I wonder which inclusion criteria were most commonly not met, and whether the criteria were changed if large numbers of potential participants were being excluded for having symptoms longer than 5 years.

    A perfect randomized trial gives an unbiased estimate of the comparative treatment effect in the sample of study participants who were enrolled and analyzed. This is known as internal validity. It is desirable to know to whom the results will apply in the real world; this is known as external validity. The burden of illness in the veterans of recent wars is immense. Of the 20 participants in this trial, 19 were victims of crime and only one was in a war. There were 17 women and 3 men. Only 3 were on disability. The study sample does not represent the Iraq and Afghanistan population which needs and deserves the best that can be offered in the way of help. That is why a separate study is needed.

    It appears that MAPS is conducting a separate trial in veterans of war. As Mark points out, this deserves public funding; it needs $500,000, and has only raised $25,000.

    The principal investigator is a board-certified psychiatrist with additional training in non-standard and alternative things like EMDR and Grof Holotropic Breathing. Most psychiatrists are not exposed to these methods, which could have been essential for this study to produce its results. The success of MDMA is critically dependent on the setting in which it is given. The interaction of drug, set, and setting, which we were discussing here recently, is well-illustrated here. The skill of the therapists, and their level of comfort with the phenomena likely to emerge during an MDMA session, is as much a part of the prescription as the drug itself.

  3. One thing I forgot to mention: MDMA is off-patent, and therefore there is no incentive for Big Pharma to fund a study, especially for a drug that will be administered only a few times, and not daily for life. Whether there are implications for the adequacy of "the free marketplace" alone to create innovations is left as a debating point.

    BTW, I did look at all the changes to the protocol that were posted on the clinicaltrials.gov website for this trial, but did not see anything relating to changes in inclusion criteria. They are still a mystery to me.

    On NPR's "Fresh Air" program recently, the guest was a psychiatrist who was lamenting the fact that only a small number of psychiatrists today are even offering psychotherapy to their patients. This too has some bearing on the problem at hand. Psychiatry has become a discipline of medication management. Sad but true, but a psychiatrist who can see four patients an hour is more "productive" than a psychiatrist who can see only one.

  4. Are these really the "first published results"? It's not my area of expertise, but I distinctly recall hearing about the therapeutic potential of MDMA from folks in the psycho-therapy business back around the late 80's or so. They spoke glowingly about its possible applications, not only for helping PTSD patients but also for assisting those coping with end-of-life issues, e.g. terminal cancer patients.

    This story sounds much like a replay. The anti-drug warriors managed to suppress all serious MDMA research back then, and since then, and there's no reason to think they'll refrain from punishing any similar heresy against their religion today. Of course I hope to be wrong about that…

  5. @Ed Whitney, the inclusion criteria was "Diagnosed with PTSD (as a result of crime victimization) OR (as a result of combat if symptoms have lasted for no longer than five years)."

    @eb, see Documents from the DEA Scheduling Hearing of MDMA, 1984-1988. Yes, pre-1985 MDMA was used by psychiatrists to successfully treat thousands of patients. The DEA had a hearing, psychiatrists and experts testified, and the DEA judge ruled that MDMA should be Schedule III (not Schedule I) because it had current medical use in the US with apparent safety.

  6. I think I see what Anonymous means; a comma between "victimization" and "or" in the protocol would have helped greatly, since it seems that there were two separate criteria. It is desirable for a study to report clearly on its eligibility criteria. This often does not happen; http://www.consort-statement.org/consort-statemen… shows that this report is not that far from the mainstream in that respect.

  7. Thanks, Anonymous. But the document you point to actually shows MDMA being briefly moved from Schedule I to Schedule III pursuant to a judge's ruling, then being returned to Schedule I by the DEA, in early 1988 (see excerpt below). Also, it's currently listed as schedule I by the DEA.

    ============ from http://www.maps.org/dea-mdma/#mdmanosched1 ===============

    17. MDMA is removed from Schedule I

    Deletion of MDMA from Schedule I following appeals court decision, Federal Register, January 27, 1988

    18. MDMA becomes a Schedule I Drug

    (the decision that stands today) DEA Scheduling of MDMA in Schedule I, Federal Register, February 22, 1988

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