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

Sunstone Medical

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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, includi…

Interventions

Drug
MDMA
MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.

Location

Sunstone Therapies
Rockville, Maryland

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

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions