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RECRUITING
NCT06679062
PHASE2

Suvorexant for Treatment of AUD and PTSD

Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

View on ClinicalTrials.gov

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

DRUG

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.

OTHER

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