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MDMA Therapy in Veterans With PTSD

NCT07569159 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-06

No results posted yet for this study

Summary

A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

MDMA

MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.

Sponsors & Collaborators

  • Sunstone Medical

    lead OTHER

Principal Investigators

  • Manish Agarwal · Sunstone Medical, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-04-01
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT07569159 on ClinicalTrials.gov