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MDMA Therapy in Veterans With PTSD

NCT07569159 · Sunstone Medical
In plain English

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Official title
A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)
About this 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.
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.
Study design
Enrollment target: 52 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06-30
Estimated completion: 2027-08
Last updated: 2026-07-01
Interventions
Drug: MDMA
Primary outcomes
  • Safety and Tolerability (15 months)
  • C-SSRS (15 months)
Sponsor
Sunstone Medical · other
Contacts & investigators
ContactClinical Evaluation Team · contact · clinical.specialists@sunstonetherapies.com · (301) 750-3401
ContactKalisha Watkins · contact · kalisha.watkins@sunstonetherapies.com
InvestigatorManish Agarwal · principal_investigator, Sunstone Medical, PC
All locations (1)
Sunstone TherapiesRecruiting
Rockville, Maryland, United States
MDMA Therapy in Veterans With PTSD · TrialPath