The safety and efficacy of _3,4-methylenedioxymethamphetamineassisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study
This study reveals how MDMA (Ecstacy) was used as a catalyst to psychotherapy to treat patients with chronic posttraumatic stress disorder. The goal of MDMA-assisted psychotherapy is to temporarily reduce fear and increase trust without inhibiting emotions, especially painful emotions, allowing these patients a window where psychotherapy for their PTSD is effective. This article identifies PTSD as a debilitating anxiety disorder currently considered as a major worldwide public health problem. The lifetime prevalence of PTSD in the general population is between 6% and 10% for US soldiers returning from Iraq and/or Afghanistan the incidence of PTSD is as high as 18% and it is estimated that those with PTSD will number between 75,000 and 225,000. The promising results of this initial pilot study offer hope for treatment of the disorder, investigators have now received the go ahead from the US (FDA) for a protocol design.
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.
Title: 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
Authors: Michael C Mithoefer, Mark T Wagner, Ann T Mithoefer, Ilsa Jerome, Rick Doblin
First published: online before print July 19, 2010