MDMA-AT for PTSD in Young Adults With Childhood Trauma (NCT07765693)
MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder in Young Adults With Childhood Trauma: An Open-Label Pilot Study
๐ฉบ Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: McLean Hospital โ Belmont, Massachusetts
Age range: 18 Years to 26 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- McLean Hospital โ Belmont, Massachusetts
๐ Contact the Study Coordinator
Phone: (617) 855-3430
Email: avelev@mclean.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Posttraumatic Stress Disorder (PTSD)
- Adaptation and Randomized Controlled Trial of Written Exposure Therapy for Adolescents โ Charleston, South Carolina
- Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder โ New York, New York
- Predictors & Mechanisms of Adolescent PTSD โ Charleston, South Carolina
- EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder โ Belmont, Massachusetts
- Extended Group Written Exposure Therapy for Comorbid PTSD and BPD (Traits) โ Hamilton, Ontario
- Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD) โ Charlestown, Massachusetts
Explore by condition: All Posttraumatic Stress Disorder (PTSD) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.