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

• Published in: Journal of psychopharmacology (Oxford) Vol. 27; no. 1; pp. 40 - 52
• Main Authors: Oehen, Peter, Traber, Rafael, Widmer, Verena, Schnyder, Ulrich
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.01.2013
• Subjects: Adult; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; N-Methyl-3,4-methylenedioxyamphetamine - administration & dosage; Pilot Projects; Psychiatric Status Rating Scales; Psychotherapy - methods; Stress Disorders, Post-Traumatic - drug therapy; Stress Disorders, Post-Traumatic - therapy; Treatment Outcome; Young Adult; PTSD; entactogen; Methylenedioxymethamphetamine; psychotherapy; MDMA-assisted psychotherapy; MDMA; posttraumatic stress disorder
• ISSN: 0269-8811; 1461-7285
• DOI: 10.1177/0269881112464827

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).