Actively Recruiting

Early Phase 1
Age: 21Years - 55Years
All Genders
Healthy Volunteers
NCT06326684

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

Age: 21Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, United States, 40507

Actively Recruiting

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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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Suvorexant and Alcohol | DecenTrialz