Suvorexant for Treatment of AUD and PTSD
Eligible age
21–65 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
You may qualify if…
- ✓ Age between 21 and 65.
- ✓ Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.
- ✓ Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score \> 30.
- ✓ Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.
- ✓ Must have an ISI score equal to or \> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.
- ✓ Agree to abstain from all other sleep medications (starting at Day -7).
- ✓ Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s/he will lose his/her housing in the next month.
You may not qualify if…
- ✕ A current (past 12-month at Day -7/-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\< moderate level on DSM 5).
- ✕ A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.
- ✕ Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6).
- ✕ Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).
- ✕ Currently pregnant, nursing, or no reliable method of birth control (females only).
- ✕ Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).
- ✕ Use of suvorexant (within 30 days of Day -7).
- ✕ Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))
Where it's recruiting
Los Angeles
Houston
Source: ClinicalTrials.gov · NCT06679062 · last updated 2026-06-23