A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Maryland
Sunstone Therapies
RECRUITING
Rockville
Contact Information
Primary
Clinical Evaluation Team
clinical.specialists@sunstonetherapies.com
(301) 750-3401
Backup
Kalisha Watkins
kalisha.watkins@sunstonetherapies.com
Time Frame
Start Date: 2026-06-30
Estimated Completion Date: 2027-08
Participants
Target number of participants: 52
Treatments
Experimental: Individual
Experimental: Group
Related Therapeutic Areas
Sponsors
Leads: Sunstone Medical