MDMA Therapy in Veterans With PTSD

Recruiting now · Phase 2

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT07569159

Run by

Sunstone Medical

People needed

52

Starts

2026-06-30

Expected to finish

2027-08-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sunstone Therapies — Rockville, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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