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Mitchell, Jennifer M; Bogenschutz, Michael; Lilienstein, Alia; Harrison, Charlotte; Kleiman, Sarah; Parker-Guilbert, Kelly; Ot'alora G, Marcela; Garas, Wael; Paleos, Casey; Gorman, Ingmar; Nicholas, Christopher; Mithoefer, Michael; Carlin, Shannon; Poulter, Bruce; Mithoefer, Ann; Quevedo, Sylvestre; Wells, Gregory; Klaire, Sukhpreet S; van der Kolk, Bessel; Tzarfaty, Keren; Amiaz, Revital; Worthy, Ray; Shannon, Scott; Woolley, Joshua D; Marta, Cole; Gelfand, Yevgeniy; Hapke, Emma; Amar, Simon; Wallach, Yair; Brown, Randall; Hamilton, Scott; Wang, Julie B; Coker, Allison; Matthews, Rebecca; de Boer, Alberdina; Yazar-Klosinski, Berra; Emerson, Amy; Doblin, Rick
Nature medicine, 06/2021, Volume: 27, Issue: 6Journal Article
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.
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