Actively Recruiting
MDMA-Assisted Massed Exposure Therapy for PTSD
Led by Emory University · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes? Participants will: * Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
CONDITIONS
Official Title
MDMA-Assisted Massed Exposure Therapy for PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of PTSD confirmed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R)
- Able to speak and read English
- Willing to sign a release for communication with primary care or mental health providers if needed
- Able to swallow pills
- Agree to have study visits audio and/or video recorded
- Willing to provide contact information for a support person
- Agree to report any medical conditions or procedures within 48 hours
- If able to become pregnant, must have negative pregnancy tests before and during the study and agree to use birth control from one month before through 10 days after the medicine session
- Agree to lifestyle modifications including fasting and medication restrictions before the medicine session, not participating in other interventional trials during the study, and following study dosing, therapy, and procedures
You will not qualify if you...
- Unable to give informed consent
- Previous participation in a MAPS-sponsored MDMA clinical trial
- Any current problem that might interfere with participation as judged by investigators
- Hypersensitivity to any ingredient of the investigational drug
- Current or past psychiatric or medical diagnoses posing risk for study participation
- Ongoing psychiatric medication use except when tapering under provider guidance
- Medical conditions that increase risk with MDMA use (e.g., uncontrolled hypertension, Wolff-Parkinson-White syndrome, ventricular arrhythmia, abnormal ECG findings, liver disease, hyponatremia, hyperthermia)
- Weight less than 48 kilograms (105 lbs.)
- Pregnant or nursing
- Recent ketamine-assisted therapy or ketamine use within 12 weeks of enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory Brain Health Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
J
Jessica Maples-Keller, PhD
CONTACT
S
Syreese Fuller
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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