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Suvorexant for Treatment of AUD and PTSD

NCT06679062 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-07-20

No results posted yet for this study

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

Interventions

DRUG

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.

OTHER

Placebo

Film coated tablet to match the active drug.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

    lead OTHER

Principal Investigators

  • Scott Lane, PhD · The University of Texas Health Science Center, Houston

  • Lara Ray, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679062 on ClinicalTrials.gov