Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484075
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-29
Brief Title:
Suvorexant for Alcohol Use Disorder AUD Neural Mechanisms
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Suvorexant for Alcohol Use Disorder AUD Neural Mechanisms
Status:
RECRUITING
Status Verified Date:
2024-10-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 3 to 4 weeks 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
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 3 to 4 weeks 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
Detailed Description:
Study Description
This protocol examines effects of a 3-4 week course of suvorexant treatment on brain dopamine receptors brain reactivity to cues and symptomatology in individuals with alcohol use disorder AUD undergoing detoxification We hypothesize that suvorexant compared to placebo will 1 increase striatal dopamine D2 receptors while decreasing the balance of D1 to D2 receptor signaling D1RD2R and 2 improve sleep and reduce alcohol craving and dysphoria
Objectives
Primary objectives To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls
Secondary Objectives To examine suvorexant s effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification
Endpoints
Primary Endpoint Suvorexant s effects on brain dopamine receptors
-Striatal dopamine D1 and D2 receptor availabilities and D1RD2R ratios
Secondary Endpoints Effects of suvorexant on
N3 REM and total sleep duration assessed with polysomnography
Self-reports of sleep quality
Self-reports of alcohol craving and mood
Exploratory Endpoints
Brain structure function chemistry and cerebrospinal fluid CSF dynamics as assessed by MRI task and resting fMRI MRS structural MRI and diffusion tensor imaging or DTI
Cognitive Test Performance
This protocol examines effects of a 3-4 week course of suvorexant treatment on brain dopamine receptors brain reactivity to cues and symptomatology in individuals with alcohol use disorder AUD undergoing detoxification We hypothesize that suvorexant compared to placebo will 1 increase striatal dopamine D2 receptors while decreasing the balance of D1 to D2 receptor signaling D1RD2R and 2 improve sleep and reduce alcohol craving and dysphoria
Objectives
Primary objectives To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls
Secondary Objectives To examine suvorexant s effects on sleep quality and alcohol craving in adults with AUD undergoing detoxification
Endpoints
Primary Endpoint Suvorexant s effects on brain dopamine receptors
-Striatal dopamine D1 and D2 receptor availabilities and D1RD2R ratios
Secondary Endpoints Effects of suvorexant on
N3 REM and total sleep duration assessed with polysomnography
Self-reports of sleep quality
Self-reports of alcohol craving and mood
Exploratory Endpoints
Brain structure function chemistry and cerebrospinal fluid CSF dynamics as assessed by MRI task and resting fMRI MRS structural MRI and diffusion tensor imaging or DTI
Cognitive Test Performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001561-AA | None | None | None |