RECRUITING

Suvorexant for Treatment of AUD and PTSD

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Quick Facts

Study Start:2025-07-16
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06679062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 21 and 65.
  2. * 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.
  3. * Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score \> 30.
  4. * 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.
  5. * 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.
  6. * Agree to abstain from all other sleep medications (starting at Day -7).
  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.
  1. * 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).
  2. * A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.
  3. * Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6).
  4. * Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).
  5. * Currently pregnant, nursing, or no reliable method of birth control (females only).
  6. * 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).
  7. * Use of suvorexant (within 30 days of Day -7).
  8. * Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))
  9. * Hepatic insufficiency (AST/ALT \> 5x upper limit of normal (ULN)).
  10. * Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.
  11. * 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.

Contacts and Locations

Study Contact

Scott Lane, PhD
CONTACT
713-486-2535
scott.d.lane@uth.tmc.edu
Lara Ray, PhD
CONTACT
lararay@psych.ucla.edu

Principal Investigator

Scott Lane, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Lara Ray, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California - Los Angeles
Los Angeles, California, 90095
United States
The University of Texas Health Science Center - Houston
Houston, Texas, 77054
United States

Collaborators and Investigators

Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

  • Scott Lane, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston
  • Lara Ray, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-07-16
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

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