MDMA Therapy in Veterans With PTSD

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

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.

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.