This randomised, double-blind, placebo-controlled Phase 2 trial (n=14) investigated MDMA-assisted psychotherapy for treatment-resistant PTSD, comparing a full dose (125 mg + optional 62.5 mg booster) versus an active placebo dose (25 mg + optional 12.5 mg booster) administered during three 8-hour therapy sessions.
The study was conducted in Biberist, Switzerland, by Dr Peter Oehen and sponsored by Lykos Therapeutics in collaboration with the Swiss Medical Society for Psycholytic Therapy. Participants were adults aged 18+ with PTSD that had not improved after at least one prior treatment. The sessions were scheduled 3-5 weeks apart, with participants receiving non-directive therapy from two co-therapists. Those in the active placebo group had the opportunity to participate in an open-label extension with full-dose MDMA.
Primary outcomes were measured using the Clinician Administered PTSD Scale (CAPS-IV) and Posttraumatic Stress Diagnostic Scale (PDS) at baseline and 3 weeks after the third session, with additional follow-ups at 6 and 12 months. The study ran from September 2006 to January 2011 and demonstrated significant results, leading to publication in the Journal of Psychopharmacology in 2013.
Trial Details
This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.Trial Number NCT00353938
Sponsors & Collaborators
MAPSMAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.
Swiss Medical Association for Psycholytic Therapy
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Papers
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)- assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)Three doses of MDMA (125mg) showed the most promise in this pilot study (n=12) of MDMA psychotherapy for PTSD. The CAPS score (PTSD measure) was just shy of significance, self-reported improvement was significant.
MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials
This pooled analysis (n=105; s=6) of MAPS' Phase II trials finds significant improvements (Cohen's d=0.8) and no significant adverse effects with MDMA-assisted therapy for PTSD. This analysis has been done to support starting the Phase III trials (which have taken place).
Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapy
A pooled analysis of participants (n=50) in Phase II MDMA trials for PTSD found that recent tapering off SSRIs may reduce treatment response (CAPS-IV score).
Long-term Follow-Up Outcomes of MDMA-assisted Psychotherapy for Treatment of PTSD: A Longitudinal Pooled Analysis of Six Phase 2 Trials
This long-term follow-up study (n=107) examines the effects of MDMA-assisted psychotherapy on PTSD symptoms. It finds a significant reduction in PTSD symptoms both at treatment exit and at least 12 months post-treatment, with 67% of participants no longer meeting PTSD criteria at long-term follow-up.