Trial PaperDepressive DisordersPTSDSuicidalitySubstance Use Disorders (SUD)Safety & Risk ManagementPublic Health, Prevention & Behaviour ChangeMDMA

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study

In a randomized, double‑blind, placebo‑controlled phase 3 trial of 90 patients with severe PTSD (including common comorbidities), MDMA‑assisted therapy produced a large, significant reduction in PTSD symptoms versus placebo (mean CAPS‑5 change −24.4 vs −13.9; P<0.0001, d=0.91) and improved functioning (SDS: P=0.0116, d=0.43). Treatment was well tolerated with no signals of abuse potential, increased suicidality or QT prolongation, indicating MDMA‑assisted therapy is a promising intervention warranting expedited evaluation.

Authors

  • Rick Doblin
  • Berra Yazar-Klosinski
  • Michael Mithoefer

Published

Nature Medicine
individual Study

Abstract

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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Study Details

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Psychedelic mushrooms in the USA: Knowledge, patterns of use and association with health outcomes

Matzopoulos, R., Morlock, A., Morlock, R. et al. · MedRvix (2021)

The effects of tryptamine psychedelics in the brain: a meta-analysis of functional and review of molecular imaging studies

Castelhano, J. M., Lima, G. M., Teixeira, M. et al. · Frontiers in Pharmacology (2021)

Psychedelic Knowledge and Opinions in Psychiatrists at Two Professional Conferences: An Exploratory Survey

Barnett, B. S., Beaussant, Y., King, K. et al. · Journal of Psychoactive Drugs (2021)

Two Models of Legalization of Psychedelic Substances: Reasons for Concern

Smith, W. R., Appelbaum, P. S. · JAMA (2021)

Psychedelic perceptions: mental health service user attitudes to psilocybin therapy

Corrigan, K., Haran, M., Mccandliss, C. et al. · Irish Journal of Medical Science (2021)

Psilocybin and MDMA for the treatment of trauma-related psychopathology

Bird, C. I. V., Modlin, N. L., Rucker, J. · International Review of Psychiatry (2021)

Acute effects of psilocybin on glutamate concentration levels, functional connectivity and subjective state

Mason, N. L., Feilding, A., Ramaekers, J. G. · European Neuropsychopharmacology (2020)

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MDMA-assisted therapy for severe PTSD: a... — Research Summary & Context | Blossom