MDMA-assisted Massed Prolonged Exposure for PTSD
Healing Breakthrough
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.
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 tre…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be a veteran (age 18-64 years old) who meets criteria for PTSD on the CAPS-5 (severity ≥ 25). 2. Be fluent in speaking and reading English. 3. Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact 4. Be able to swallow pills. 5. Agree to have study visits audio and/or video recorded, including MDMA session, assessments, and PE sessions, and aware that Independent Rater assessments for PE sessions will occur. 6. Have a contact able to drive the participant home after the MD…
Interventions
- Drug3,4 Methylenedioxymethamphetamine
1 MDMA session
- BehavioralProlonged 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
Location
- VA San Diego Healthcare System, San Diego, CASan Diego, California