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Suvorexant for Alcohol Use Disorder (AUD) and PTSD

This study is looking at whether suvorexant, a medication, can help reduce sleep problems (insomnia) in 76 men and women who have both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) symptoms. Participants will be between 21 and 65 years old. You would first have a 7-day period where you receive a placebo (an inactive pill), then you would be randomly assigned to receive either suvorexant or a matching placebo for 14 additional days. During this time, you would try to stop drinking alcohol and complete daily diaries. The main goal is to see if suvorexant improves your insomnia score after 14 days.

Study design
This is a randomized, double-masked (meaning neither you nor the study staff will know if you're getting the active drug or placebo), placebo-controlled study with about 76 participants.
What's involved
You would have a 7-day placebo run-in period, followed by 14 days of receiving either suvorexant or placebo. You would also complete daily virtual diaries and attend in-person clinic visits on days 7 and 14.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia will be measured at the start of the study (Day 0) and again on Day 14.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06679062

Suvorexant for Treatment of AUD and PTSD

Recruiting
PHASE2Ages 21–65InterventionalTreatment
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
~76 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:SuvorexantPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insomnia Severity Index (ISI) score from baseline to Day 14.
Measured over Baseline (Day 0) and Day 14

Conditions

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

Explore related trials

Alcohol use disorderInsomniaPost-Traumatic Stress Disorder

Where it's being run

2 sites across 2 states
California1
Texas1

Study leadership

  • Scott Lane, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
  • Lara Ray, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Scott Lane, PhD
[email protected]
713-486-2535
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Insomnia Severity Index (ISI) score from baseline to Day 14.Baseline (Day 0) and Day 14

    The Insomnia Severity Index (ISI) is a brief questionnaire to screen for insomnia in participants. A scoring system is used to identify what degree insomnia (if any detected) is affecting daily life and sleep patterns. A total score is derived by summing all seven items with a total score ranging from 0 to 28 (with higher scores indicative of worse insomnia symptoms).