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Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

NCT06484075 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-15

No results posted yet for this study

Summary

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

  • Healthy Volunteers
  • Alcohol Use Disorder (AUD)

Interventions

DRUG

Placebo

The placebo will be a tablet, but only containing inert inactive ingredients.

DRUG

Suvorexant

Drug approved for improving sleep

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Nora D Volkow Adler, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06484075 on ClinicalTrials.gov