RecruitingPhase 2NCT06418178

Dose Optimization of MDMA-Assisted Therapy for PTSD

A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans


Sponsor

Bronx VA Medical Center

Enrollment

60 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of MDMA-assisted therapy — a treatment that combines a controlled dose of MDMA (sometimes known as "ecstasy") with structured psychotherapy sessions — to find the most effective and safest dose for treating PTSD (post-traumatic stress disorder) in military veterans. **You may be eligible if...** - You are a U.S. military veteran aged 18 or older - You have a current diagnosis of PTSD - You are able to swallow pills - You agree to have study sessions recorded - You can provide a contact person who can be reached in case of emergency - If you can become pregnant, you agree to use contraception and test negative for pregnancy before each treatment session **You may NOT be eligible if...** - You have a medical condition that makes taking a stimulant-type drug dangerous (e.g., uncontrolled high blood pressure, heart conditions) - You have significant psychiatric or medical history that poses a safety concern - You have symptomatic liver disease - You have a history of dangerously low sodium or abnormal body temperature - You weigh less than 48 kg (approximately 106 lbs) - You currently abuse drugs or alcohol - You have recently received electroconvulsive therapy (ECT) or ketamine therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMidomafetamine

One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)

BEHAVIORALPsychotherapy

Standardized psychotherapy performed by therapy team


Locations(1)

James J. Peters VA Medical Center

The Bronx, New York, United States

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NCT06418178


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