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Suvorexant and Alcohol

NCT06326684 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-23

No results posted yet for this study

Summary

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

Interventions

DRUG

Alcohol

The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.

DRUG

Placebo

The effects of placebo will be determined.

DRUG

Suvorexant

The effects of suvorexant dose 1 will be determined.

DRUG

Suvorexant

The effects of suvorexant dose 2 will be determined.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • William Stoops

    lead OTHER

Principal Investigators

  • William W Stoops, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2027-03-15
Completion
2027-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326684 on ClinicalTrials.gov