MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder in Young Adults With Childhood Trauma: An Open-Label Pilot Study
Jenna M. Traynor
Summary
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT). The main questions it aims to answer are: * Is the treatment safe and feasible to administer? * Does the treatment improve PTSD symptoms? Participants will be asked to: * Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation * Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session * Attend three integration talk therapy sessions after each MDMA-AT dosing session * Attend up to three total MDMA-AT dosing sessions * Complete assessments from baseline to 38-weeks post-baseline * Complete a fMRI scan at baseline and at 18-weeks post-treatment * Complete self-report measures and ecological momentary assessments (EMAs) across the study period
Eligibility
- Age range
- 18–26 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Demographic and Participant Information * Between the ages of 18-26 years old upon signing the written consent form * Proficient in speaking and reading English. * Capable of providing informed consent. * Is able to swallow pills. * Willing and able to be contacted by phone throughout the study * Resides in the United States * Meets DSM-5 criteria for PTSD with sufficient severity assessed at study screening * History of index Criterion A trauma that occurred in childhood * Must agree to inform the research team within 48 hours of any emerging or new medical conditions an…
Interventions
- DrugMDMA assisted psychotherapy
Recruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy.
Location
- McLean HospitalBelmont, Massachusetts