3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.
Journal of psychopharmacology (Oxford, England) – December 01, 2018
Source: PubMed
Summary
Many battling posttraumatic stress disorder (PTSD) find little relief from standard therapies. A promising approach explored how 3,4-Methylenedioxymethamphetamine (MDMA) combined with psychotherapy could help. Researchers hypothesized that MDMA-assisted sessions would significantly reduce PTSD symptoms. Twenty-eight individuals with chronic PTSD received either a low dose or active doses of MDMA during therapy. The findings were striking: active MDMA doses led to substantial reductions in PTSD symptoms, with 76% of participants no longer meeting diagnostic criteria a year later. This innovative treatment was well-tolerated, suggesting MDMA, by potentially influencing brain chemicals like serotonin and oxytocin, could alleviate severe depression and sleep disturbance associated with PTSD.
Abstract
Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms. This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams. Twenty-eight people with chronic posttraumatic stress disorder were randomized in a double-blind dose response comparison of two active doses (100 and 125 mg) with a low dose (40 mg) of MDMA administered during eight-hour psychotherapy sessions. Change in the Clinician-Administered PTSD Scale total scores one month after two sessions of MDMA served as the primary outcome. Active dose groups had one additional open-label session; the low dose group crossed over for three open-label active dose sessions. A 12-month follow-up assessment occurred after the final MDMA session. In the intent-to-treat set, the active groups had the largest reduction in Clinician-Administered PTSD Scale total scores at the primary endpoint, with mean (standard deviation) changes of -26.3 (29.5) for 125 mg, -24.4 (24.2) for 100 mg, and -11.5 (21.2) for 40 mg, though statistical significance was reached only in the per protocol set ( p=0.03). Posttraumatic stress disorder symptoms remained lower than baseline at 12-month follow-up ( p<0.001) with 76% ( n=25) not meeting posttraumatic stress disorder criteria. There were no drug-related serious adverse events, and the treatment was well-tolerated. Our findings support previous investigations of MDMA-assisted psychotherapy as an innovative, efficacious treatment for posttraumatic stress disorder.