The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study

This first placebo-controlled study (n=20) showed that 83% of participants in the active treatment group didn’t qualify for PTSD anymore (CAPS score). This study was the one that highlighted the promise of MDMA-assisted psychotherapy for PTSD.

Abstract

“Case reports indicate that psychiatrists administered ±3,4-methylenedioxymethamphetamine (MDMA) as a catalyst to psychotherapy before recreational use of MDMA as ‘Ecstasy’ resulted in its criminalization in 1985. Over two decades later, this study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct. Twenty patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacology, were randomly assigned to psychotherapy with concomitant active drug (n = 12) or inactive placebo (n = 8) administered during two 8-h experimental psychotherapy sessions. Both groups received preparatory and follow-up non-drug psychotherapy. The primary outcome measure was the Clinician-Administered PTSD Scale, administered at baseline, 4 days after each experimental session, and 2 months after the second session. Neurocognitive testing, blood pressure, and temperature monitoring were performed. After 2-month follow-up, placebo subjects were offered the option to re-enroll in the experimental procedure with open-label MDMA. Decrease in Clinician-Administered PTSD Scale scores from baseline was significantly greater for the group that received MDMA than for the placebo group at all three time points after baseline. The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments.”

Authors: Michael C. Mithoefer, Mark T. Wagner, Ann T. Mithoefer, Lisa Jerome & Rick Doblin

Notes

This study was preceded by Bouso et al. (2008) but that study only used lower dosages (also with a PTSD affected population).

A further analysis of the data on personality changes, notably Openness and Neuroticism was done by Wagner and colleagues (2017).

A long-term 17-74 months follow-up was done by Mithoefer and colleauges in 2012.

This study was sponsored by MAPS.

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