Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
About this trial
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.
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Eligibility criteria
This trial accepts healthy volunteersQualifiers
All Participants
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, ages 18-75 years old.
Ability to understand and the willingness to sign a written informed consent document.
Disqualifiers
Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI.
Cannot lie comfortably flat on his/her back for up to 2 hours in the MRI scanner.
Body weight > 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.
Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugThe placebo will be a tablet, but only containing inert inactive ingredients.
Suvorexant
DrugDrug approved for improving sleep
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Non treatmentNo intervention 0 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Group C: SuvorexantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls.
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.
Time frame
3 yearsSecondary outcomes
1
To examine suvorexant's effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification.
We hypothesize that suvorexant compared to placebo will improve sleep and reduce alcohol craving and dysphoria.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov