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Randomized Controlled Trial
. 2013 Jan;27(1):28-39.
doi: 10.1177/0269881112456611. Epub 2012 Nov 20.

Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study

Michael C Mithoefer  1 , Mark T Wagner, Ann T Mithoefer, Lisa Jerome, Scott F Martin, Berra Yazar-Klosinski, Yvonne Michel, Timothy D Brewerton, Rick Doblin
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Free PMC article
Randomized Controlled Trial

Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study

Michael C Mithoefer et al. J Psychopharmacol. 2013 Jan.
Free PMC article

Abstract

We report follow-up data evaluating the long-term outcomes for the first completed trial of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for chronic, treatment-resistant post-traumatic stress disorder (PTSD) (Mithoefer et al., 2011). All of the 19 subjects who received MDMA-assisted treatment in the original trial participated in the long-term follow-up (LTFU), with 16 out of 19 completing all of the long-term outcome measures, which were administered from 17 to 74 months after the original study's final MDMA session (mean = 45.4; SD = 17.3). Our primary outcome measure used was the Clinician-Administered PTSD Scale (CAPS). Secondary outcome measures were the Impact of Events Scale-Revised (IES-R) and the Neuroticism Extroversion Oppenness Personality Inventory-Revised (NEO PI-R) Personality Inventory. We also collected a long-term follow-up questionnaire. Results for the 16 CAPS completers showed there were no statistical differences between mean CAPS score at LTFU (mean = 23.7; SD = 22.8) (t (matched) = 0.1; df = 15, p = 0.91) and the mean CAPS score previously obtained at Study Exit (mean = 24.6, SD = 18.6). On average, subjects maintained statistically and clinically-significant gains in symptom relief, although two of these subjects did relapse. It was promising that we found the majority of these subjects with previously severe PTSD who were unresponsive to existing treatments had symptomatic relief provided by MDMA-assisted psychotherapy that persisted over time, with no subjects reporting harm from participation in the study.

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Conflict of interest statement

Conflict of interest: Our sponsor played a role in the study design, data analysis and writing of the report (the investigators performed all data collection). Three authors, Berra Yazar-Klosinski, Lisa Jerome and Rick Doblin, are employed by the sponsor. Michael Mithoefer is a medical monitor for other studies of MDMA-assisted psychotherapy that are currently being conducted by the sponsor. He and Ann Mithoefer both received payment from the sponsor for conducting this research, while also working on the development of a treatment manual, investigator training program, and the design of protocols for additional studies planned by the sponsor. The sponsor paid Mark Wagner for acting as the independent rater for this study.

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Figure 1.
Figure 1.
Study design with number of participants.
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