Suvorexant for insomnia in people with alcohol use disorder and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Scott Lane, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Scott Lane, PhD
• Email: scott.d.lane@uth.tmc.edu
• Phone: 713-486-2535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.