NCT07569159PHASE2Recruiting
MDMA Therapy in Veterans With PTSD
Sunstone Medical
Start Date
6/30/2026
Completion Date
8/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
MDMA
Conditions
Post Traumatic Stress Disorder
Locations
Sunstone Therapies
Rockville, Maryland 20850
United States