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Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD

NCT04784143 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-07-15

Study results available
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Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is effective in U.S. military veterans with at least moderate chronic PTSD. The main question it aims to answer is: Are two versus three MDMA-assisted therapy sessions in an outpatient treatment clinic more effective?

Researchers will compare two MDMA-assisted therapy sessions to three MDMA-assisted therapy sessions.

Participants will undergo three non-drug preparatory sessions prior to their first MDMA-assisted therapy session. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.

Conditions

Interventions

DRUG

Midomafetamine

120 mg midomafetamine HCl followed by a supplemental dose of 60 mg

BEHAVIORAL

Psychotherapy

Manualized psychotherapy performed by therapist team

Sponsors & Collaborators

Principal Investigators

  • Rachel Yehuda · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2024-06-25
Completion
2024-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784143 on ClinicalTrials.gov