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.
Michael C Mithoefer, Mark T Wagner, Ann T Mithoefer, Lisa Jerome, Scott F Martin, Berra Yazar-Klosinski, Yvonne Michel, Timothy D Brewerton, Rick Doblin
Journal of psychopharmacology (Oxford, England) 2013 DOI: 10.1177/0269881112456611 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Long-term follow-up of a completed trial Peer reviewed |
|---|---|
| Sample size | 19 |
| Population | Adults with chronic, treatment-resistant PTSD |
| Intervention | MDMA-assisted psychotherapy |
| Duration | 17 to 74 months follow-up after final MDMA session (mean 45.4 months) |
| Topics | Psychedelic-assisted therapy MDMA PTSD |
| Keywords | MDMA-Assisted Psychotherapy MDMA Therapy Ecstasy therapy Psycholytic therapy Trauma therapy Chronic PTSD Treatment Severe PTSD Treatment Refractory PTSD Treatment Long-term efficacy Sustained relief Durable recovery Lasting outcomes Prolonged benefits Follow-up results Sustained improvements Mental health research Psychiatric research Psychological study Clinical investigation Mental well-being study Follow-up study |
| Citations | 377 |
| Key findings | MDMA-assisted psychotherapy provided durable symptom relief for most participants with chronic, treatment-resistant PTSD over an average of 45.4 months, with no reported harm. |
Abstract
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.