MDMA-assisted Massed Prolonged Exposure for PTSD — MDMA-PE  

Post-Traumatic Stress Disorder Clinical Trial

Official title: MDMA-assisted Massed Prolonged Exposure for PTSD

Status Not yet recruiting

Clinical Trial 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 full-dose MDMA and veterans who receive low-dose MDMA.

Clinical Trial 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 veterans will be randomized in a 1:1 ratio to receive MDMA in a standard dose (120 mg MDMA HCl, ~102 mg MDMA, rounded) or low dose (40 mg MDMA HCl, ~34 mg MDMA) 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 up to 3-weeks. PE will involve eleven 90-minute sessions with the initial two sessions both occurring during the first treatment visit 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 include the first imaginal exposure. Participants will report SUDS at the start and end of imaginal exposure. Imaginal exposures will be recorded, and participants will listen to this recording as homework. Following a modified version of the MAPS Preparatory session criteria, we also will provide psychoeducation regarding MDMA's subjective effects and strategies for MDMA-related support after a 30-minute break following the PE session. Visit 4 will include the MDMA administration. 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 30-minute break before the PE session. Visits 5-12 will include imaginal exposures and processing of the in-session experience. Each day 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 within 1 week, 2 months, and 4 months after treatment. ;

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT06117306
• Study type: Interventional
• Source: San Diego Veterans Healthcare System
• Contact: Leslie A Morland, Psy.D.
• Phone: 858-226-5765
• Email: Leslie.Morland@va.gov
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2, 2024
• Completion date: January 1, 2026