Suvorexant for Treatment of AUD and PTSD

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Study ID
NCT06679062
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

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

Locations (2)

FacilityCityStateZIPSite coordinators
University of California - Los AngelesLos AngelesCalifornia90095
Lara Ray, PhD
[email protected]
Jessica Jenkins
[email protected]
Lara Ray, PhD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center - HoustonHoustonTexas77054
Scott Lane, PhD
[email protected]
Jessica Vincent
[email protected]
Scott Lane, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
University of California - Los Angeles· Los Angeles, CAThe University of Texas Health Science Center - Houston· Houston, TX

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