Actively Recruiting
Suvorexant for Treatment of AUD and PTSD
Led by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Updated on 2025-07-20
76
Participants Needed
2
Research Sites
45 weeks
Total Duration
On this page
Sponsors
P
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Suvorexant for Treatment of AUD and PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 65.
- Meet current DSM-5 criteria for moderate or severe alcohol use disorder.
- Currently have PTSD symptoms with a PCL-5 score over 30.
- Motivated to reduce or quit drinking within the next 6 months and to receive PTSD treatment.
- Have an Insomnia Severity Index (ISI) score of 7 or higher.
- Agree to avoid all other sleep medications starting at Day -7.
- Have stable housing for at least 2 weeks before randomization and no risk of losing it in the next month.
You will not qualify if you...
- Current diagnosis of substance use disorder for drugs other than alcohol, nicotine, or marijuana at a moderate level or higher.
- Lifetime diagnosis of schizophrenia, bipolar disorder, or psychotic disorder.
- Positive urine test for recreational drugs other than marijuana at screening.
- Clinically significant alcohol withdrawal (CIWA-Ar score of 10 or higher).
- Currently pregnant, nursing, or no reliable birth control method (for females).
- Significant medical conditions that prevent safe study participation (e.g., narcolepsy, seizure disorder, serious cardiovascular, liver, kidney, neurological, or endocrine problems).
- Use of suvorexant within 30 days before Day -7.
- Use of prescription medications that interact with suvorexant.
- Liver dysfunction with AST/ALT levels more than 5 times the upper limit.
- Suicidal ideation above moderate severity.
- Unable to prove 48-hour alcohol abstinence at Day 0 after two attempts.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of California - Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
The University of Texas Health Science Center - Houston
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
S
Scott Lane, PhD
CONTACT
L
Lara Ray, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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