Recruiting

Suvorexant on Brain Dopamine Receptors in Alcohol Use Disorder

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Study Aim

This study aims to evaluate how suvorexant affects brain dopamine receptors in adults with alcohol use disorder during detoxification and compare these effects to healthy individuals.

What is being tested

Placebo

+ Suvorexant

Drug
Who is being recruted

Alcoholism+2

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 75 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ContactMichele-Vera I Yonga, C.R.N.P.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 21, 2024

Actual date on which the first participant was enrolled.

This study aims to explore how a medication called suvorexant affects the brain and behavior of people with Alcohol Use Disorder (AUD) who are undergoing detoxification. The focus is on understanding how suvorexant impacts certain brain receptors related to dopamine, a chemical involved in pleasure and reward. The researchers believe that suvorexant might help improve sleep, reduce cravings for alcohol, and lessen negative moods. This research could potentially lead to better treatment options for those struggling with alcohol addiction by addressing issues like poor sleep and cravings, which are common challenges during recovery. Participants in this study will take suvorexant or a placebo for 3-4 weeks. The effects on their brain will be monitored using advanced imaging techniques, and changes in sleep patterns will be measured with sleep studies. Participants will also provide feedback on their sleep quality and alcohol cravings. The study will assess changes in brain chemistry, structure, and function, as well as cognitive performance. The potential risks involve typical side effects related to the suvorexant medication, but the benefits could include improved sleep and reduced cravings, which are crucial for successful detoxification and recovery.

Official TitleSuvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
NCT06484075
Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ContactMichele-Vera I Yonga, C.R.N.P.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlcoholismMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

Criteria

1 inclusion criteria required to participate
Self-reported insomnia/sleep problems: PSQI score > 4 and/or endorsing "problems falling asleep or staying asleep throughout the night".

6 exclusion criteria prevent from participating
Current benzodiazepine, opioids, or stimulant misuse (must have misused 5+ days/week for >1 year, and most recent use must have been within 7 days of inpatient admission).

Body weight > 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.

Severe head trauma with loss of consciousness > 60 minutes.

Montgomery-Asberg depression rating scale (MADRS) total score > 35 or 'suicidal thoughts' item score > 3, indicating severe depression or moderate suicidality, respectively.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
AUD subjects randomized to receive placebo for up to 28 days during inpatient treatment.

Group II

Active Comparator
AUD subjects randomized to receive Suvorexant (20 mg po) for up to 28 days during inpatient treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center