NCT06117306

MDMA-assisted Massed Prolonged Exposure for PTSD

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Healing Breakthrough · Unknown
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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 different doses of MDMA.

Detailed description

The study is a randomized pilot study that will evaluate the preliminary efficacy, safety, tolerability, and acceptability of the intervention in a sample of U.S. veterans seeking PTSD treatment at the VASDHS. Ten to twenty veterans will be randomized to receive a dose of MDMA (exact range not disclosed) based on the 2-week Emory MDMA-PE Protocol developed by Maples-Keller and Rothbaum. The current protocol will entail massed-PE and the MDMA administration spanning approximately 3-weeks. PE will involve twelve 90-minute sessions with the initial two sessions both occurring during the first treatment visit, the third and fourth sessions occurring during the MDMA session, and the remaining sessions occurring daily or every other day (M-F for two to three weeks). Following the baseline assessment during Visit 1, participants will begin PE during Visit 2, which will include psychoeducation, rationale for exposure-based treatment, discussion of the SUDS scale, and creating the in vivo exposure hierarchy. Visit 3 will be the Preparatory Session, in which we will provide psychoeducation regarding MDMA's subjective effects and strategies for MDMA-related support. Visit 4 will include the MDMA administration, which will include the third and fourth PE sessions, including the first and second imaginal exposures. Participants will report SUDS at the start and end of imaginal exposure. At the beginning of Visit 5, following a modified version of the MAPS Integration session criteria, the therapist and patient will focus on developing a deeper understanding of insights from the MDMA session and any thoughts or feelings regarding the patient's experience of PTSD and its impact on their life. After the Integration session there will be a break before the PE session. Visits 5-12 will include imaginal exposures and processing of the in-session experience. Imaginal exposures will be recorded, and participants will listen to this recording as homework. Each visit an in vivo exposure will be assigned for homework; all sessions will begin with a check-in that includes reviewing this exposure experience. The post-treatment questionnaire assessment will occur on Visit 13. Participants will complete post-treatment follow-up CAPS-5 clinical interviews remotely approximately 1 week, 2 months, and 4 months after treatment. Following the 2-month follow-up assessment and unblinding, veterans may be offered an optional additional MDMA session and up to three optional additional integration sessions depending on the dose they received. Participants will be invited to enroll in an optional fMRI (brain imaging) sub-study where, if eligible and interested, they will undergo fMRI brain scans pre- and post-treatment.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	3,4 Methylenedioxymethamphetamine	1 MDMA session
BEHAVIORAL	Prolonged Exposure	12 90-minute PE sessions; initial two sessions both occurring during the first treatment visit, third and fourth sessions occurring during the MDMA session, and the remaining sessions occurring daily or every other day

Timeline

• Start date: 2024-10-25
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-11-07
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study