RecruitingPhase 2

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

United States250 participantsStarted 2025-12-04

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Heavy Drinking Days

Timeframe: 8-week treatment period

Startle eyeblink potentiation

Timeframe: Baseline; 4-weeks; 8-weeks

Alcohol Craving Via Ecological Momentary Assessment (EMA)

Timeframe: 8-week treatment period

Trial details

NCT IDNCT07214207

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09

Contact for this trial

Stephanie Gorka

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

View on ClinicalTrials.gov More Alcohol Use Disorder trials