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NCT06679062 | NOT YET RECRUITING | Alcohol Use Disorder (AUD)

Suvorexant for Treatment of AUD and PTSD
Sponsor:

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

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.

Condition or disease

Alcohol Use Disorder (AUD)

Post Traumatic Stress Disorder (PTSD)

Insomnia

Intervention/treatment

Suvorexant

Placebo

Phase

PHASE2

Detailed Description:

This is a randomized, double-masked, placebo-controlled study to evaluate preliminary efficacy and safety of suvorexant (SUV) (20mg) for sleep disturbance in alcohol use disorder (AUD) and co-occurring posttraumatic stress disorder (PTSD) symptoms in approximately 76 randomized men and women veteran and non-veterans between the ages 21-65. Participants will be recruited from the University of Texas Health Science Center at Houston (UTHealth) Trauma and Recovery Center (TRC) and the University of California - Los Angeles (UCLA) (in collaboration with West Los Angeles VA Medical Center). Following a 7-day placebo run-in, participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)) or matched placebo. Randomization will be stratified on sex and level of sleep disturbance (Insomnia Severity Index (ISI) score). Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. The alcohol cue-reactivity paradigm is an established laboratory assessment of craving during which participants are exposed to real alcohol and water cues in a bar laboratory setting. Participants will then take their first dose of medication. Participants will begin the real-world quit attempt, during which they will attempt to stop drinking for two weeks. Participants will complete daily virtual diaries and visits to assess sleep, past-day drinking, and alcohol craving. Participants will return to one of the clinical sites on study Day 14 to complete an alcohol cue-reactivity session to assess post-medication craving. PTSD symptoms will be assessed via Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) and Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) at baseline, at Day 7 and at Day 14 of treatment with SUV or matched placebo.

Study Type : INTERVENTIONAL
Estimated Enrollment : 76 participants
Masking : TRIPLE
Masking Description : 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.
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-02
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Suvorexant for Treatment of AUD and PTSD

Location Details

NCT06679062

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How to Participate

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Locations

Not yet recruiting

United States, California

University of California - Los Angeles

Los Angeles, California, United States, 90095

Not yet recruiting

United States, Texas

The University of Texas Health Science Center - Houston

Houston, Texas, United States, 77054