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ENROLLING BY INVITATION
NCT05746572
PHASE2

MDMA Plus Exposure Therapy for PTSD

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

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.

Official title: A Pilot Study of MDMA-Assisted Massed Exposure Therapy for PTSD (MDMA PE)

Key Details

Gender

All

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-02-13

Completion Date

2026-05-29

Last Updated

2026-01-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

MDMA

Participants will receive MDMA HCl (100 mg, 84 mg MDMA) in combination with massed exposure therapy for PTSD.

Locations (1)

Emory Brain Health Center

Atlanta, Georgia, United States