A Pilot Study of MDMA-Assisted Massed Exposure Therapy for PTSD (MDMA PE)
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.
- Status
- enrolling by invitation
- Phase
- Phase 2
- Institution
- Emory University
- Principal investigator
- Jessica Maples-Keller, PhD
- Start date
- 2024-02-13
- End date
- 2026-10-31
- Registry ID
- NCT05746572
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.