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RECRUITING Phase 2 ClinicalTrials.gov

Suvorexant for Treatment of AUD and PTSD

Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance • ClinicalTrials.gov ID: NCT06679062

Registry updated: 2026-10-14
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Description

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.

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.
  • Placebo (Other)
    Film coated tablet to match the active drug.

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.

Conditions

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

Locations

  • University of California - Los Angeles — Los Angeles, California, United States
  • The University of Texas Health Science Center - Houston — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record