Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.
Lisa Jerome, Allison A. Feduccia, Julie B. Wang, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Michael C Mithoefer, Rick Doblin
Psychopharmacology August 1, 2020 Retracted DOI: 10.1007/s00213-020-05548-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Long-term follow-up of multiple clinical trials Open-label Longitudinal Peer reviewed |
|---|---|
| Population | Participants with chronic PTSD |
| Intervention | MDMA-assisted psychotherapy |
| Dose | 75-125 mg |
| Duration | At least 12 months post final MDMA session |
| Topics | MDMA Psychedelic-assisted therapy PTSD |
| Keywords | Long-term follow-up MDMA-Assisted Psychotherapy PTSD Treatment Trauma therapy Mental health treatment PTSD Recovery PTSD Management MDMA Therapy Therapeutic MDMA Drug-assisted psychotherapy MDMA Treatment Sustained relief Enduring effects Follow-up study Long-term outcomes Lasting relief Chronic PTSD Improvement |
| Citations | 163 |
| Registration | NCT00090064 NCT00353938 NCT01958593 NCT01211405 NCT01689740 NCT01793610 |
| Key findings | PTSD symptoms were significantly reduced 1-2 months after MDMA-assisted psychotherapy, and symptom improvement continued for at least 12 months post-treatment. |
Abstract
Posttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD. To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD. Participants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire. There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation. PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD. clinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.
Comparable studies
Other non-randomized and open-label trials on MDMA and psychedelic-assisted therapy, most cited first.