At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years old
- ✓Willing to comply with study procedures and duration
- ✓Ability to understand and sign informed consent
- ✓DSM 5 diagnosis of moderate or severe AUD (AUD participants only)
- ✕Ferromagnetic objects contraindicated for MRI, fear of enclosed spaces, or standard MRI contraindications
- ✕Unable to lie flat for up to 2 hours in MRI scanner
- ✕Body weight >400 lbs
- ✕Previous radiation exposure exceeding NIH annual research limits
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
In Brief
A Phase 1 clinical trial evaluating Placebo and Suvorexant for Healthy Volunteers and Alcohol Use Disorder (AUD). Currently recruiting, targeting 180 participants across 1 site.
Detailed 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. ...
Study Details
Timeline
Arms & Interventions
Healthy Volunteers will receive two PET scans and one MRI session without any treatment.
AUD subjects randomized to receive placebo for up to 28 days during inpatient treatment.
AUD subjects randomized to receive Suvorexant (20 mg po) for up to 28 days during inpatient treatment.
Interventions
The placebo will be a tablet, but only containing inert inactive ingredients.
Drug approved for improving sleep