Actively Recruiting
Suvorexant and Alcohol
Led by William Stoops · Updated on 2025-12-23
30
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
W
William Stoops
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
CONDITIONS
Official Title
Suvorexant and Alcohol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to speak and read English
- Not seeking treatment at the time of the study
- Between the ages of 21 and 55 years
- Engaging in at least one binge drinking episode in the last 30 days
- Meeting moderate or severe DSM-5 criteria for Alcohol Use Disorder based on psychiatric evaluation
- ECG within normal limits as read by a cardiologist
- Body mass index between 19 and 35
- If birthing individuals, using effective birth control and not pregnant or breastfeeding
- Judged psychiatrically and physically healthy by medical staff with no severe disorders other than AUD or Tobacco Use Disorder
- Not physiologically dependent on any substances
- Able to abstain from alcohol during admission and scoring less than 8 on alcohol withdrawal assessment
- Not currently on prescribed medications for chronic conditions except birth control
- No indication of sleep apnea (STOP-Bang score below 5)
- No allergies or contraindications to suvorexant
You will not qualify if you...
- Seeking treatment for alcohol use at the time of the study
- Presence of severe substance use disorder or psychiatric diagnoses other than Alcohol Use Disorder or Tobacco Use Disorder
- Physiological dependence on any substances
- Inability to abstain from alcohol during admission
- Use of prescribed medications for chronic conditions other than birth control
- Indications of sleep apnea (STOP-Bang score of 5 or greater)
- Allergies or contraindications to suvorexant
- ECG abnormalities outside normal limits
- Pregnancy or breastfeeding without effective birth control
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, United States, 40507
Actively Recruiting
Research Team
W
William W Stoops, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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