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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, Mark T Wagner, Ann T Mithoefer, Lisa Jerome, Scott F Martin, Berra Yazar-Klosinski, Yvonne Michel, Timothy D Brewerton, Rick Doblin

Journal of Psychopharmacology 2013 DOI: 10.1177/0269881112456611 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Long-term follow-up of a completed trial Peer reviewed
Sample size 19
Population Adults with chronic, treatment-resistant PTSD
Intervention MDMA-assisted psychotherapy
Duration 17 to 74 months follow-up after final MDMA session (mean 45.4 months)
Topics Psychedelic-assisted therapy MDMA PTSD
Keywords MDMA-Assisted Psychotherapy MDMA Therapy Ecstasy therapy Psycholytic therapy Trauma therapy Chronic PTSD Treatment Severe PTSD Treatment Refractory PTSD Treatment Long-term efficacy Sustained relief Durable recovery Lasting outcomes Prolonged benefits Follow-up results Sustained improvements Mental health research Psychiatric research Psychological study Clinical investigation Mental well-being study Follow-up study
Citations 377
Key findings MDMA-assisted psychotherapy provided durable symptom relief for most participants with chronic, treatment-resistant PTSD over an average of 45.4 months, with no reported harm.

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.

In the evidence

This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.

  • State of the evidence: MDMA and psychedelic-assisted therapy Supports

    Mean CAPS scores at long-term follow-up (mean 45.4 months) did not differ from study exit, indicating maintained gains, though two participants relapsed.

    Synthesized

  • State of the evidence: MDMA for PTSD Supports

    Gains in symptom relief were maintained over a mean of 45 months after MDMA-assisted psychotherapy, with no evidence of harm or drug dependency, though two participants relapsed.

    Synthesized

  • State of the evidence: PTSD Supports

    Gains from MDMA-assisted psychotherapy were maintained over a mean 45.4 months with no statistical difference from study exit scores, though two participants relapsed.

    Synthesized

  • State of the evidence: Psychedelic-assisted therapy Supports

    Gains in PTSD symptom relief were maintained over an average of 45 months, with two relapses and no reported harm or drug dependency.

    Synthesized

Comparable studies

Other non-randomized and open-label trials on MDMA and psychedelic-assisted therapy, most cited first.

Study Year Design Participants
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Patients with alcohol use disorder (AUD) following community alcohol detoxification 2021 Open-label safety and tolerability proof-of-concept study n = 14
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants. Patients with alcohol use disorder 2019 Open-label safety and tolerability proof of concept study n = 4
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil. Patients with PTSD secondary to sexual abuse 2021 Open-label clinical trial n = 3
Group psychedelic therapy: empirical estimates of cost-savings and improved access Adults with PTSD or major depressive disorder eligible for psychedelic-assisted therapy... 2023 Comparative cost analysis using trial data and published estimates

Citations in the library

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Cites 29

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