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NCT06484075 · ClinicalTrials.gov registry record · Phase 1
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
A Phase 1 study of Healthy Volunteers and Alcohol Use Disorder (AUD), sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT06484075: Recruiting Phase 1 study of Healthy Volunteers and Alcohol Use Disorder (AUD), sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT06484075 is a Phase 1 study of Healthy Volunteers and Alcohol Use Disorder (AUD) that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 180 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06484075, a Phase 1 study of Healthy Volunteers and Alcohol Use Disorder (AUD), is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study 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. ...
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Suvorexant
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
What NCT06484075 shows while recruiting
NCT06484075 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06484075 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06484075 about?
NCT06484075 is a clinical study titled "Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms". 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 ...
What is the current status of trial NCT06484075?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2024-11-21. Estimated completion is 2029-12-31.
What conditions does trial NCT06484075 study?
This clinical trial studies the following conditions: Healthy Volunteers, Alcohol Use Disorder (AUD).
What interventions are being tested in trial NCT06484075?
The interventions under investigation include: Placebo (DRUG), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT06484075?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06484075 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06484075's enrollment target sits among peer trials
180 52nd of 283 higher than 232 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
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