Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder
Julie B. Wang, Jessica Lin, Leah Bedrosian, Allison Coker, Ilsa Jerome, Allison Feduccia, Alia Lilienstein, Charlotte Harrison, Elizabeth Heimler, Michael 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
Summary
AI-generated from the abstractMDMA-assisted therapy (MDMA-AT) can be scaled across multiple clinic sites while maintaining high treatment fidelity. In an open-label study across 14 North American sites, cotherapist dyads were trained in a manualized protocol and administered three experimental sessions to participants with severe PTSD. Adherence to the therapy protocol was high across both dyads and sites. PTSD symptom severity, measured by the CAPS-5, decreased substantially after three sessions at 18 weeks. MDMA was well tolerated. These results indicate that the benefits of MDMA-AT for PTSD can be achieved in a multi-site, real-world clinical setting.
Study at a glance
| 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 |
| Keywords | PTSD Treatment Trauma therapy Mental health treatment Psychiatric care Psychological intervention |
| Citations | 22 |
| Key finding | 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.