Recruiting
Phase 2

Suvorexant

Sponsor:

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Code:

NCT06679062

Conditions

Alcohol Use Disorder (AUD)

Post Traumatic Stress Disorder (PTSD)

Insomnia

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Suvorexant

Placebo

Study Details

Brief summary:

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

Alcohol Use Disorder (AUD)

Post Traumatic Stress Disorder (PTSD)

Insomnia

Study ID

NCT06679062

Start date

Jul 16, 2025

Status verified date

Oct, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 10mg and 20mg Suvorexant (SUV)

Participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)).

placebo comparator: Placebo

Participants will be randomly assigned to receive matched placebo (Days 0-13).

Interventions

Suvorexant

Suvorexant is described chemically as: \[(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl\]\[5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl\]methanone. SUV's empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Each film coated tablet contains 10mg or 20mg of suvorexant.

Placebo

Film coated tablet to match the active drug.

Primary outcome measure

  • Change in Insomnia Severity Index (ISI) score from baseline to Day 14. [ Time Frame: Baseline (Day 0) and Day 14 ]

Central Contacts and Locations

Central contacts

Scott Lane, PhD

713-486-2535scott.d.lane@uth.tmc.edu

Lara Ray, PhD

lararay@psych.ucla.edu

Locations

The University of Texas Health Science Center - Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Scott Lane, PhD

scott.d.lane@uth.tmc.edu

Jessica Vincent

jessica.n.vincent@uth.tmc.edu

Principal Investigator:

Scott Lane, PhD

More Information

Sponsor

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.