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MDMA Therapy for Veterans with PTSD

This study is testing MDMA (a ring-substituted phenylisopropylamine derivative) combined with therapy for veterans who have Post Traumatic Stress Disorder (PTSD). Researchers want to see how safe and well-tolerated MDMA is, and if it helps with PTSD symptoms. You might be able to join if you are a veteran at least 18 years old, can swallow pills, and can complete study assessments in English. The study aims to enroll 52 participants. The current status of the study is unclear.

Study design
This is a Phase 2, single-center study. It is open-label, meaning both you and the study team will know what treatment you are receiving. It plans to include 52 participants.
What's involved
You would take a 120 mg dose of oral MDMA, followed by a supplemental 60 mg dose, in conjunction with therapy. You would also need to complete all required assessment tools and attend study visits.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be measured at 15 months after starting the study.

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NCT07569159

MDMA Therapy in Veterans With PTSD

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sunstone Medical
~52 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:MDMA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 15 months
+1 more outcome measured

Conditions

Post Traumatic Stress Disorder

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Manish Agarwal · PRINCIPAL_INVESTIGATOR · Sunstone Medical, PC

Who to contact

Clinical Evaluation Team
[email protected]
(301) 750-3401
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Veterans who are at least 18 years old
Are able to swallow pills
Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Proficient in speaking and reading English.

Exclusion

Condition impairing oral intake or digestive absorption.
Unable to give adequate informed consent.
Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months
Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)
A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.
Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.

What this trial measures

  • Safety and Tolerability15 months

    To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.

  • C-SSRS15 months

    Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) score at all visits from Baseline to EOS Visit.