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.

Trial Details

Posttraumatic stress disorder (PTSD) is a debilitating disorder. While effective treatments exist, some patients fail to receive the full benefits. Alternative treatment approaches are needed. 3,4-methylenedioxymethamphetamine (MDMA) is a medicine associated with feelings of closeness and love for others, empathy, insightfulness, and feelings of peace or well-being. Recent research combining one or two doses of MDMA with psychotherapy has shown improvements in PTSD symptoms. For the present study, the researchers will investigate MDMA in combination with Prolonged Exposure therapy (PE), a gold-standard treatment for PTSD. All participants receive MDMA on the second day of a 10-day PE treatment program in which a PE therapy session occurs each day. This study will occur at the Emory Brain Health Center. Potential participants will be recruited via community advertising and mental health referrals. The research team will also collect psychophysiological data for exploratory analyses regarding how MDMA may improve PE treatment for PTSD. This is an important study as it is the first time MDMA will be combined with an evidence-based existing PTSD treatment. The study population will consist of people who meet the criteria for PTSD and are medically appropriate for MDMA administration.

NCT Number NCT05746572

Data attribution

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