RecruitingPhase 2NCT06679062

Suvorexant for Treatment of AUD and PTSD

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)

Sponsor

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Enrollment

76 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Insomnia Post Traumatic Stress Disorder (PTSD)Alcohol Use Disorder (AUD)

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.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests suvorexant — an FDA-approved sleep medication — to see if it can treat both alcohol use disorder (AUD) and PTSD (post-traumatic stress disorder) simultaneously, since the two conditions commonly occur together and both involve disrupted sleep. **You may be eligible if...** - You are 21–65 years old - You meet the diagnostic criteria for moderate or severe alcohol use disorder - You are currently experiencing PTSD symptoms (score above 30 on the PCL-5 questionnaire) - You are motivated to reduce your drinking - You are medically safe to participate (blood pressure, liver function within safe ranges) **You may NOT be eligible if...** - You have severe liver disease - You are dependent on other substances (other than alcohol or nicotine) - You are currently taking medications that strongly interact with suvorexant - You have active suicidal ideation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSuvorexant

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.

OTHERPlacebo

Film coated tablet to match the active drug.