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Suvorexant for Treatment of AUD and PTSD
Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Summary
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.
Official title: A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-07-16
Completion Date
2026-06
Last Updated
2025-07-20
Healthy Volunteers
No
Interventions
Suvorexant
Suvorexant is described chemically as: \[(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl\]\[5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl\]methanone. SUV's empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Each film coated tablet contains 10mg or 20mg of suvorexant.
Placebo
Film coated tablet to match the active drug.
Locations (2)
University of California - Los Angeles
Los Angeles, California, United States
The University of Texas Health Science Center - Houston
Houston, Texas, United States