Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study

• Published in: Journal of psychopharmacology (Oxford) Vol. 27; no. 1; pp. 28 - 39
• Main Authors: Mithoefer, Michael C, Wagner, Mark T, Mithoefer, Ann T, Jerome, Lisa, Martin, Scott F, Yazar-Klosinski, Berra, Michel, Yvonne, Brewerton, Timothy D, Doblin, Rick
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.01.2013
• Subjects: Adult; Female; Follow-Up Studies; Humans; Male; N-Methyl-3,4-methylenedioxyamphetamine - adverse effects; N-Methyl-3,4-methylenedioxyamphetamine - therapeutic use; Outcome Assessment (Health Care); Prospective Studies; Psychotherapy - methods; Street Drugs - adverse effects; Stress Disorders, Post-Traumatic - drug therapy; Stress Disorders, Post-Traumatic - therapy; Substance-Related Disorders - drug therapy; Surveys and Questionnaires; Treatment Outcome; PTSD; post-traumatic stress disorder; mental health; psychotherapy methods; pharmacotherapy; ecstasy; long-term outcome; psychedelic drugs; victimization; MDMA; treatment resistance
• ISSN: 0269-8811; 1461-7285
• DOI: 10.1177/0269881112456611

We report follow-up data evaluating the long-term outcomes for the first completed trial of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for chronic, treatment-resistant post-traumatic stress disorder (PTSD) (Mithoefer et al., 2011). All of the 19 subjects who received MDMA-assisted treatment in the original trial participated in the long-term follow-up (LTFU), with 16 out of 19 completing all of the long-term outcome measures, which were administered from 17 to 74 months after the original study’s final MDMA session (mean = 45.4; SD = 17.3). Our primary outcome measure used was the Clinician-Administered PTSD Scale (CAPS). Secondary outcome measures were the Impact of Events Scale-Revised (IES-R) and the Neuroticism Extroversion Oppenness Personality Inventory-Revised (NEO PI-R) Personality Inventory. We also collected a long-term follow-up questionnaire. Results for the 16 CAPS completers showed there were no statistical differences between mean CAPS score at LTFU (mean = 23.7; SD = 22.8) (t matched = 0.1; df = 15, p = 0.91) and the mean CAPS score previously obtained at Study Exit (mean = 24.6, SD = 18.6). On average, subjects maintained statistically and clinically-significant gains in symptom relief, although two of these subjects did relapse. It was promising that we found the majority of these subjects with previously severe PTSD who were unresponsive to existing treatments had symptomatic relief provided by MDMA-assisted psychotherapy that persisted over time, with no subjects reporting harm from participation in the study.