Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder
Julie B. Wang, Jessica Lin, Leah Bedrosian, Allison R. Coker, Ilsa Jerome, Allison A. Feduccia, Alia Lilienstein, Charlotte Harrison, Elizabeth Heimler, Michael C Mithoefer, Annie Mithoefer, Marcela Ot’alora G., Bruce Poulter, Shannon Carlin, Rebecca Matthews, Berra Yazar-Klosinski, Amy Emerson, Rick Doblin
Journal of Humanistic Psychology June 23, 2021 DOI: 10.1177/00221678211023663 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label multi-site clinical trial Peer reviewed |
|---|---|
| Sample size | 37 |
| Population | Participants with severe PTSD |
| Intervention | MDMA-assisted therapy |
| Duration | Three experimental sessions 3 to 5 weeks apart, with assessment at 18 weeks post baseline |
| Topics | Psychedelic-assisted therapy MDMA |
| Keywords | PTSD Treatment Trauma therapy Mental health treatment Psychiatric care Psychological intervention MDMA-Assisted Therapy MDMA Therapy Drug-assisted psychotherapy Empathogen therapy Therapeutic psychedelics Clinical trials Multi-site study Research study Clinical research Drug trials Therapy trials Efficacy study Scalability study |
| Citations | 22 |
| Key findings | MDMA-assisted therapy produced significant reductions in PTSD symptom severity and was scalable across 14 North American sites with high protocol adherence. |
Abstract
Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized therapy across 14 North American sites.
Method: Cotherapist dyads were trained in the manualized MDMA-AT protocol and administered three experimental sessions 3 to 5 weeks apart among participants with severe PTSD. Cotherapist dyads were provided clinical supervision and evaluated for protocol adherence by centralized raters. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) assessed change in symptoms severity.
Results: Adherence rating scores were high across cotherapist dyads ( M = 95.08%, SD = 3.70%) and sites ( M = 95.23%, SD = 2.20%). CAPS-5 scores decreased following 3 MDMA-AT sessions at 18 weeks post baseline (Δ M = −29.99, Δ SD = 13.45, p < .0001, n = 37, Cohen’s d = 2.2, confidence interval [1.97, 2.47]). MDMA was well tolerated.
Conclusions: These findings corroborate previous results that MDMA-AT can achieve significant improvements in PTSD symptom severity and demonstrate scalability of manualized therapy across clinic sites in the United States and Canada.