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.