RecruitingPhase 1/2

Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

United States180 participantsStarted 2024-11-21

Plain-language 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. ...

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕All Participants
✕If a subject's urine drug/breath alcohol (\>=0.08%) screen test is positive on days involving imaging (MRI and/or PET) and NP testing, the procedures will be postponed until BrAC \<0.08. This is not expected to happen in most cases especially since participants will have been detoxifying for 1-5 days (possibly longer) and should no longer test positive for BrAC at this point. After initial screening under 14AA0181, subjects will be in the inpatient unit detoxifying.
✕Control Participants

What they're measuring

To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.

Timeframe: 3 years

Trial details

NCT IDNCT06484075

SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Michele-Vera I Yonga, C.R.N.P.

(301) 273-4169 michelevera.yonga@nih.gov

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