MDMA-assisted Massed Prolonged Exposure for PTSD

This Phase III interventional trial (n=10), sponsored by Healing Breakthrough, will assess the efficacy, safety, and acceptability of MDMA-assisted Massed Prolonged Exposure (MDMA-PE) therapy for veterans with PTSD.

Conducted at the San Diego Veterans Healthcare System, the trial aims to determine the effect of full-dose MDMA (120mg) compared to low-dose MDMA (40mg) alongside prolonged exposure therapy. The study involves 10 veterans who will be randomly assigned to receive either standard or low-dose MDMA. The protocol includes 11 non-medicine sessions of prolonged exposure therapy, with MDMA administration during the fourth session. Subsequent sessions involve processing the MDMA experience alongside exposure therapy.

Assessments will include clinician-rated PTSD symptoms, self-reported PTSD symptoms, depressive symptoms, functioning, sleep quality, safety, and satisfaction with care.

Participants will be followed up remotely for 4 months post-treatment. The trial started in January 2024 and is estimated to be completed in January 2026 with an enrollment of 10 participants.

Topic PTSD
Compound MDMA
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 02 January 2024
End date 01 January 2026
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 10
Sex All
Age 18- 99
Therapy Yes

Trial Details

The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive full-dose MDMA and veterans who receive low-dose MDMA.

Trial Number NCT06117306

Sponsors & Collaborators

Healing Breakthrough
Healing Breakthrough is a non-profit organization dedicated to addressing the urgent need for improved treatment options for veterans suffering from post-traumatic stress disorder (PTSD).

US Department of Veteran Affairs
The US Department of Veteran Affairs is playing an important role in the psychedelic renaissance by exploring and monitoring advancements in psychedelic therapies and the viability of these therapies for veterans with PTSD.

Data attribution

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