Actively Recruiting
Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
Led by Ohio State University · Updated on 2025-12-11
250
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 614 standard drinks per week if male, and 67 standard drinks per week if female
- Self-reported treatment-seeking for alcohol use disorder
You will not qualify if you...
- Clinically significant medical or neurologic condition or neurocognitive dysfunction affecting function or study participation, including sleep disorders, 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 other than alcohol or mild cannabis use disorder
- Currently pregnant, lactating, or not agreeing to use birth control during the trial (women)
- Use of medications for alcohol use disorder or psychotropic medications
- Current use of antihistamines or medications that increase risk as determined by the study physician
- Current use of strong or moderate CYP3A liver enzyme inhibitors or 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
- Smoking 10 or more cigarettes or electronic equivalents per day
- Obesity with body mass index (BMI) of 30 or higher
- Clinically significant alcohol withdrawal symptoms on lab days (CIWA-Ar score >10)
- Unwilling or unable to sign informed consent
- Under 18 or over 65 years old at enrollment
- Suicide attempt in past 3 years or current suicidal ideation greater than moderate by C-SSRS
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
S
Stephanie Gorka
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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