NCT06484075

Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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. ...

Detailed description

Study Description: This protocol examines effects of a 10-28 day course of suvorexant treatment on brain dopamine receptors, brain reactivity to cues and symptomatology in individuals with alcohol use disorder (AUD) undergoing detoxification. We hypothesize that suvorexant compared to placebo will (1) increase striatal dopamine D2 receptors while decreasing the balance of D1 to D2 receptor signaling (D1R/D2R) and (2) improve sleep and reduce alcohol craving and dysphoria. Objectives: Primary objectives: To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls. Secondary objectives: To examine suvorexant's effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification. Endpoints: Primary Endpoint: Suvorexant's effects on brain dopamine receptors: -Striatal dopamine D1 and D2 receptor availabilities and D1R/D2R ratios Secondary Endpoints: Effects of suvorexant on: * N3, REM, and total sleep duration (assessed with polysomnography) * Self-reports of sleep quality * Self-reports of alcohol craving and mood Exploratory Endpoints: * Brain structure, function, chemistry and cerebrospinal fluid (CSF) dynamics as assessed by MRI (task and resting fMRI, MRS, structural MRI, and diffusion tensor imaging or DTI) * Cognitive Test Performance

Conditions

• Healthy Volunteers
• Alcohol Use Disorder (AUD)

Interventions

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

Timeline

• Start date: 2024-11-21
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-07-03
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study