Recruiting
Phase 2

Suvorexant

Sponsor:

Ohio State University

Code:

NCT07214207

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Suvorexant 10 mg

Placebo

Study Details

Brief summary:

The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are:

  • Is SUV effective for AUD?
  • Does SUV dampen stress reactivity?
  • Can the researchers develop a biomarker for SUV treatment response?

Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD.

Participants will:

  • Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks.
  • Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG).
  • Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.

Conditions

Alcohol Use Disorder

Study ID

NCT07214207

Start date

Dec 4, 2025

Status verified date

Dec, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Generally medically and neurologically healthy;
  • Age 18 to 65 at the time of consent;
  • Willing and able to give informed consent;
  • Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
  • Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
  • Self-reported treatment-seeking for alcohol use disorder

Exclusion Criteria:

  • Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders;
  • Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
  • Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
  • Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
  • Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
  • Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined by the study physician;
  • Current use of strong or moderate inhibitors of CYP3A liver enzymes;
  • Current use of strong CYP3A inducers;
  • Current use of digoxin;
  • Liver function tests more than 3 times the upper limit of normal or elevated bilirubin;
  • Engages in night shift work;
  • Smoke 10 or more cigarettes (or electronic equivalent) per day and are thus susceptible to acute nicotine withdrawal during lab visits;
  • Obesity as defined by a body-mass index (BMI) equal or greater than 30, as calculated from weight and height self-report;
  • Clinically significant alcohol withdrawal symptoms the day of the lab sessions, defined as a score >10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar);
  • Unwilling/unable to sign the informed consent document;
  • Under 18 years old or over 65 years old at the time of enrollment;
  • Have attempted suicide in the past 3 years and/or have current suicidal ideation determined as greater than moderate via the Columbia Suicide Severity Rating Scale (C-SSRS)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control

Individuals will take a placebo pill daily for 8-weeks.

experimental: Suvorexant

Individuals will take 10mg of suvorexant (Merck \& Co Inc.) daily for 8-weeks.

Interventions

Suvorexant 10 mg

This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4 weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial.

Placebo

This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial.

Primary outcome measure

  • Proportion of Heavy Drinking Days [ Time Frame: 8-week treatment period ]
  • Startle eyeblink potentiation [ Time Frame: Baseline; 4-weeks; 8-weeks ]
  • Alcohol Craving Via Ecological Momentary Assessment (EMA) [ Time Frame: 8-week treatment period ]

Central Contacts and Locations

Central contacts

Stephanie Gorka

614-366-1027stephanie.gorka@osumc.edu

Locations

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • suvorexant
  • alcohol use disorder
  • electromyography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-12-11.