Dose Optimization of MDMA-Assisted Therapy for PTSD (DosOp)

This open-label, within-subjects dose optimisation trial (n=60) will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

The trial, sponsored by Bronx VA Medical Center and led by Rachel Yehuda, aims to determine the optimal number of treatment cycles of MDMA-AT for significant improvement in PTSD symptoms. Participants will undergo three non-drug preparatory sessions and at least one MDMA-assisted therapy cycle, each consisting of an approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions.

The decision to continue with additional cycles will be made collaboratively by participants and their therapy team based on symptom burden and treatment response.

The study also involves collecting blood samples for future biomarker analysis. The trial is set to start in October 2024 and is estimated to complete by October 2029.

Trial Details

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

NCT Number NCT06418178

Data attribution

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