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)
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Dr. Michael Mithoefer has been flown to New York City and is being interviewed today
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Were still waiting on DEA to issue Dr. Mithoefer his Schedule I license
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MAPS submits a Freedom of Information Act (FOIA) request to FDA
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Dr. Mithoefer learned today that on December 11, 2003, the South Carolina DEA office submitted
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The New York Times: Research on Ecstasy Is Clouded by Errors
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The politics of Research
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The British newspaper The Guardian published a positive article today
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MAPS MDMA/PTSD research team met in Charleston, South Carolina
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Dr. Mithoefer receives his Schedule I research registration
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RTI Denies it Made Mistake
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DEA Inspection Goes Very Well
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Protocol Improvements Recommended by IRBs
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MAPS sends a letter to all members of the National Institute on Drug Abuse
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Promising news from DEA
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Nature publishes a short news story
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MAPS Submits FOIA Request to NIDA
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Triumph
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MAPS Sent a Letter to NIDA Director Nora Volkow
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Another Independent IRB
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Drs. Mithoefer, Jerome and Doblin have written a letter