Suvorexant for Treatment of AUD and PTSD

NCT06679062 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AS210006-A10
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index (ISI) score from baseline to 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).

  Baseline (Day 0) and Day 14

Secondary Outcomes (6)

• Change in cue-induced alcohol craving, as assessed by the Alcohol Urge Questionnaire (AUQ) during the alcohol condition, from baseline to day 14.

  Baseline (Day 0) and Day 14

• Change in mean number of drinks per drinking day from baseline to Day 14.

  Baseline (Day 0) and Day 14

• Percent total days abstinent during the 14-day quit attempt period.

  Baseline (Day 0) through Day 14

• Change in the mean number of days abstinent during the medication period (day 0 through 14) compared to the 30-days prior (screening period).

  Screening (30-days prior to baseline) and Baseline through Day 14

• Change in PTSD total symptom severity score as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to Day 14.

  Baseline (Day 0) through Day 14

Study Arms (2)

10mg and 20mg Suvorexant (SUV)

ACTIVE COMPARATOR

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

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Suvorexant DRUG

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.

Also known as: SUV, Dual orexin receptor antagonist

10mg and 20mg Suvorexant (SUV)

Placebo OTHER

Film coated tablet to match the active drug.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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))
• 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.

Sponsors & Collaborators

• Pharmacotherapies for Alcohol and Substance Use Disorders Alliance: lead
• University of California, Los Angeles: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (2)

University of California - Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

The University of Texas Health Science Center - Houston

Houston, Texas, 77054, United States

RECRUITING

Related Publications (1)

• Ray LA, Nieto SJ, Miotto K, Mooney L, LeBeau R, Yoon JH, Schmitz JM, Acierno R, Bailey NW, Jenkins J, Vincent J, Nolen T, Hirsch S, Williams A, Lane SD. Suvorexant for alcohol use disorder and post-traumatic stress disorder: study protocol for a phase II randomized clinical trial. Trials. 2026 Feb 3. doi: 10.1186/s13063-026-09489-7. Online ahead of print.

  PMID: 41630040 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

suvorexant; Orexin Receptor Antagonists

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Scott Lane, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Lara Ray, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Lane, PhD

CONTACT

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

Lara Ray, PhD

CONTACT

lararay@psych.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: To minimize bias, all participants will be screened for assurance that they meet study eligibility criteria. A placebo drug will be employed as the comparison group to active study drug and the study will be conducted in a double-blinded fashion in that both the participants and the site investigators and staff interacting with participants and assessing study outcomes will be blinded to treatment assignment. The only individuals at the site with access to treatment assignment information will be the research pharmacists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be given a placebo run-in (Day -7 to Day -1). On baseline (Day 0), the participant will be randomized to receive SUV or placebo (1:1 ratio) and administered 10mg SUV or placebo for an additional 7 days (Day 0 to Day 6). On Day 7, the participant previously randomized to SUV will be given 20 mg SUV, and participant previously randomized to placebo will continue with placebo.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)