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MDMA Therapy in Veterans With PTSD

RecruitingPhase 2

A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

About the study

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.

What is being tested

Sponsor: Sunstone Medical · Participants: 52 · Started: Jun 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07569159

Locations in the U.S.

MarylandSunstone Therapies, Rockville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.