Actively Recruiting
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-04-27
180
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain. Objective: To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people. Eligibility: People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed. Design: Participants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD. Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking. Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay. Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan. Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies. Imaging scans and other tests will be repeated at the end of the study. Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week. ...
CONDITIONS
Official Title
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to follow all study procedures and be available for the study duration
- Male or female aged 18 to 75 years
- Ability to understand and sign informed consent
- For AUD participants: diagnosis of moderate or severe AUD
- Seeking treatment for AUD
- At least 5 years history of heavy drinking
- Last alcohol use within 7 days before enrollment
- Self-reported sleep problems or insomnia
- Ability and willingness to take oral medication and follow study drug regimen
- Commitment to at least 28 days and up to 40 days inpatient stay
- Agreement to follow lifestyle considerations during the study
You will not qualify if you...
- Presence of ferromagnetic objects contraindicated for MRI or fear of enclosed spaces
- Unable to lie flat for up to 2 hours for MRI
- Body weight over 400 lbs
- Prior radiation exposure exceeding safe limits
- Pregnant or breastfeeding females; females of childbearing potential must have negative pregnancy tests
- History of severe head trauma with loss of consciousness over 60 minutes
- Chronic psychotic disorders like schizophrenia or bipolar 1 disorder
- Severe depression or suicidality as assessed by MADRS
- Major medical problems impacting brain function (e.g., seizures, stroke, Alzheimer's, Parkinson's, HIV)
- Severe liver impairment indicated by liver enzyme levels over five times normal
- Non-English speakers
- For AUD participants: current daily use of certain medications (stimulants, modafinil, wellbutrin, naltrexone, antipsychotics, strong CYP3A inhibitors)
- Current misuse of benzodiazepines, opioids, or stimulants
- Severe substance use disorders other than alcohol, cannabis, nicotine, or caffeine unless in remission at least 6 months
- Medical conditions contraindicating suvorexant use (narcolepsy, severe sleep apnea, REM behavioral disorder)
- For healthy controls: psychiatric disorders requiring daily psychoactive medications recently
- History of moderate or severe substance use disorders except nicotine or caffeine
- Use of multiple medications that affect brain function in past 2 months
- Positive drug or alcohol screens on imaging or testing days may delay or exclude participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Michele-Vera I Yonga, C.R.N.P.
CONTACT
N
Nora D Volkow Adler, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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