Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland
This objective of this study was to determine whether three eight-hour long sessions of MDMA-assisted therapy, scheduled three to five weeks apart, could be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with therapy, when compared with a low (“active placebo”) dose of MDMA, would reduce PTSD symptoms. Participants were randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or “active placebo” dose of MDMA (25 mg) during each of three Experimental Sessions.
We found that MDMA-assisted therapy could be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in Clinician Administered PTSD Scale (CAPS) scores (p = 0.066), although there was clinically and statistically significant self-reported improvement in PTSD as measured by the Posttraumatic Diagnostic Scale (PDS) (p = 0.014) and CAPS scores improved further at the 1-year follow-up. We also found that three MDMA-assisted therapy sessions were more effective than two (p = 0.016).
- Current Status: Completed
- ClinicalTrials.gov Record
- Study Protocol
- Letter to the Editor
- Study Timeline