Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

NCT07214207 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY20250713R01AA032711
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

suvorexant; alcohol use disorder; electromyography

Outcome Measures

Primary Outcomes (3)

• Proportion of Heavy Drinking Days

  Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days.

  8-week treatment period

• Startle eyeblink potentiation

  Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.

  Baseline; 4-weeks; 8-weeks

• Alcohol Craving Via Ecological Momentary Assessment (EMA)

  Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving).

  8-week treatment period

Secondary Outcomes (5)

• Drinks Per Day

  8-week treatment period

• Proportion of Days Abstinent

  8-week treatment period

• Transdermal Alcohol Concentration (TAC)

  8-week treatment period

• Phosphatidylethanol (PEth) levels

  4-weeks; 8-weeks

• Subjective Stress Levels via Ecological Momentary Assessment

  8-week treatment period

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Placebo

Suvorexant

EXPERIMENTAL

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

Drug: Suvorexant 10 mg

Interventions

Suvorexant 10 mg DRUG

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.

Also known as: Belsomra

Suvorexant

Placebo OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Stephanie Gorka

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be submitted to the NIAAA Data Archive biannually per NIAAA requirements throughout the duration of the study.

Locations

US (1)