A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)

MDMA-assisted psychotherapy for treatment-resistant PTSD can be safely administered in a clinical setting. In a randomized, double-blind, active-placebo controlled pilot trial, 12 patients received either a low dose (25 mg plus 12.5 mg supplemental) or a full dose (125 mg plus 62.5 mg supplemental) of MDMA during three experimental sessions, combined with weekly non-drug psychotherapy. No serious drug-related adverse events occurred. While clinician-rated PTSD symptoms (CAPS) did not show statistically significant reductions (p = 0.066), self-reported improvement (PDS) was clinically and statistically significant (p = 0.014). CAPS scores further improved at one-year follow-up, and three MDMA sessions were more effective than two (p = 0.016).

Study at a glance

Abstract

Psychiatrists and psychotherapists in the US (1970s to 1985) and Switzerland (1988–1993) used MDMA legally as a prescription drug, to enhance the effectiveness of psychotherapy. Early reports suggest that it is useful in treating trauma-related disorders. Recently, the first completed pilot study of MDMA-assisted psychotherapy for PTSD yielded encouraging results. Designed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD; our randomized, double-blind, active-placebo controlled trial enrolled 12 patients for treatment with either low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose). MDMA was administered during three experimental sessions, interspersed with weekly non-drug-based psychotherapy sessions. Outcome measures used were the Clinician-Administered PTSD Scale (CAPS) and the Posttraumatic Diagnostic Scale (PDS). Patients were assessed at baseline, three weeks after the second and third MDMA session (end of treatment), and at the 2-month and 1-year follow-ups. We found that MDMA-assisted psychotherapy can be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in CAPS scores ( p = 0.066), although there was clinically and statistically significant self-reported (PDS) improvement ( p = 0.014). CAPS scores improved further at the 1-year follow-up. In addition, three MDMA sessions were more effective than two ( p = 0.016).