MDMA Plus Exposure Therapy for PTSD

This Phase IV interventional trial (n=40) aims to investigate the efficacy and safety of MDMA (84-100mg) in combination with Prolonged Exposure therapy (PE) for individuals with posttraumatic stress disorder (PTSD).

Conducted by Emory University, the study focuses on the effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms, measured by changes in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score. Participants will receive MDMA (100 mg, 84 mg MDMA) in combination with massed exposure therapy for PTSD during a 10-day treatment program, with MDMA administration occurring on the second day.

The study, estimated to start in January 2024 and complete in December 2025, will assess primary and secondary outcomes, including changes in self-reported PTSD symptoms measured by the PTSD Checklist for DSM-5 (PCL-5). The research team, led by Principal Investigators Jessica Maples-Keller, PhD, and Barbara O Rothbaum, PhD, will conduct this groundbreaking study at the Emory Brain Health Center in Atlanta, Georgia, United States. Participants must meet criteria for PTSD and be willing to undergo daily therapy sessions and MDMA administration.

The study also involves psychophysiological data collection for exploratory analyses on how MDMA may enhance PE treatment for PTSD. This trial marks the first time MDMA is combined with an evidence-based existing PTSD treatment, addressing the need for alternative approaches for patients who do not fully benefit from conventional treatments.

Eligible participants, aged 21 to 70, are recruited through community advertising and mental health referrals and must comply with specific lifestyle modifications, including fasting and refraining from certain medications before the Medicine Session. The study’s estimated enrollment is 40 participants, and contact information for inquiries is provided.

Topic PTSD
Compound MDMA
Country United States of America
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Sponsors & Collaborators

Emory University
Emory University has recently launched the Center for Psychedelics and Spirituality (ECPS). The centre will combine expertise in psychiatry with spiritual health to better understand the therapeutic promise of psychedelics as medicine.

Data attribution

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