Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ID
NCT06484075
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Alcohol Use Disorder (AUD)
  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    The placebo will be a tablet, but only containing inert inactive ingredients.
  • Suvorexant — DRUG
    Drug approved for improving sleep

Study Details

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. ...

Key Dates

Start date
Nov 21, 2024
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Non treatment
    Healthy Volunteers will receive two PET scans and one MRI session without any treatment.
  • Placebo Comparator: Placebo
    AUD subjects randomized to receive placebo for up to 28 days during inpatient treatment.
  • Active Comparator: Suvorexant
    AUD subjects randomized to receive Suvorexant (20 mg po) for up to 28 days during inpatient treatment.

Primary Outcome Measure

To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls. [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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