Suvorexant for insomnia in people with alcohol use disorder 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)

This study will test whether suvorexant can reduce insomnia in adults 21–65 who have moderate-to-severe alcohol use disorder and PTSD symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (Academic / other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT06679062 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-masked, placebo-controlled Phase 2 trial enrolling about 76 veterans and non-veterans aged 21–65 with co-occurring AUD and PTSD symptoms and insomnia (ISI ≥7). After a 7-day placebo run-in, participants are randomized to suvorexant (titrated 10 mg Days 0–6, 20 mg Days 7–13) or matched placebo for 14 days. Before the first dose participants complete an alcohol cue-reactivity session, then begin a real-world two-week quit attempt while completing daily virtual diaries and clinic assessments on Days 7 and 14. Outcomes include sleep measures, past-day drinking, and alcohol craving collected via diaries and in-person visits at UCLA (Los Angeles) or UTHealth (Houston).

Who should consider this trial

Good fit: Adults 21–65 with moderate or severe DSM-5 AUD, PTSD symptoms (PCL-5 > 30), an ISI score ≥7, motivation to reduce or quit drinking, willingness to stop other sleep medications, and stable housing are the ideal candidates.

Not a fit: People without clinically significant insomnia (ISI <7), those with a current substance use disorder other than alcohol or nicotine, those unwilling to attempt a brief quit, or those unable to attend required clinic visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, suvorexant could improve sleep in people with AUD and PTSD and may help reduce craving or support short-term drinking reductions during a quit attempt.

How similar studies have performed: Suvorexant is an approved insomnia medication and orexin antagonists have some preclinical and early human data suggesting effects on craving, but using suvorexant specifically for co-occurring AUD and PTSD is relatively novel and not yet well established.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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))
* Hepatic insufficiency (AST/ALT \> 5x upper limit of normal (ULN)).
* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.
* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.

Where this trial is running

Los Angeles, California and 1 other locations

• University of California - Los Angeles — Los Angeles, California, United States (Recruiting)
• The University of Texas Health Science Center - Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Scott Lane, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Scott Lane, PhD

Conditions Alcohol Use Disorder; Post Traumatic Stress Disorder; Insomnia