Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
This study was the first formal FDA-approved scientific study of the therapeutic use of MDMA-assisted therapy in any patient population. This study was a randomized, double-blind placebo-controlled pilot study of the safety and efficacy of MDMA-assisted therapy on symptoms of chronic, treatment-resistant PTSD.. Findings from this study were used to guide development of follow-up pilot studies to refine and standardize MDMA-assisted therapy for PTSD patients.
This study tested whether MDMA-assisted therapy could be safely administered to people with treatment-resistant PTSD or veterans with PTSD symptoms that have endured for one to five years who were unable or unwilling to undergo conventional psychotherapy or pharmacotherapy for PTSD. The study also determined whether two experimental sessions of MDMA-assisted therapy produced improvement in PTSD signs and symptoms four days after each of the sessions, and again at follow-up evaluation two months after the last session.
“MDMA-assisted therapy can be administered to PTSD patients without evidence of harm.”
Results from this showed a decrease in Clinician-Administered PTSD Scale (CAPS) scores from baseline that were significantly greater for the MDMA group than for the placebo group. The rate of clinical response was 83% in the active treatment group versus 25% in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects, or clinically significant blood pressure increases. This study showed that MDMA-assisted therapy can be administered to PTSD patients without evidence of harm, and it may be useful in patients refractory to other treatments.
On July 27, 2010, data collection was completed for the long-term follow-up to this study. We collected Clinician-Administered PTSD Scale (CAPS) measurements from 17 of the 20 subjects who received treatment. All 20 subjects filled out a questionnaire developed internally to assess long-term effects. The average length of time between the final Experimental Session and the follow-up data collection was 3½ years. The long-term follow-up found that the benefits persisted over time, though a few subjects had relapsed due to new life stressors.
- Current Status: Completed
- Clinicaltrials.gov Record
- Study Protocol
- Original Publication (2010)
- Long-Term Follow-Up Publication (2012)
- Study Timeline