Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269627
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-17
Brief Title:
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05-30
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
Chronic heavy drinking can cause alcohol use disorder AUD AUD changes how the brain works People with AUD may drink compulsively or feel like they cannot control their alcohol use Acamprosate is an FDA-approved drug that reduces anxiety and craving in some but not all people with AUD
Objective
To learn more about how acamprosate affects brain function in people with AUD
Eligibility
People aged 21 to 65 years with moderate to severe AUD
Design
Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days
Acamprosate is a capsule taken by mouth Half of participants will take this drug 3 times a day with meals The other half will take a placebo The placebo looks like the study drug but does not contain any medicine Participants will not know which capsules they are taking
Participants will have a procedure called electroencephalography EEG A gel will be applied to certain locations on their scalp and a snug cap will be placed on their head The cap has sensors with wires The sensors detect electrical activity in the brain Participants will lie still and perform 2 tasks they will look at different shapes and press a button when they see a specific one and they will listen to tones and press dedicated buttons when they hear the corresponding tones
Participants will have 2 EEGs 1 on day 2 and 1 on day 23 of their study participation They may opt to have up to 4 more EEG studies one on day 13 and one on each of the three follow-up visits and 2 sleep studies in which they would have sensors attached to their scalp while they sleep
Participants may have up to three follow-up visits for 6 months
Chronic heavy drinking can cause alcohol use disorder AUD AUD changes how the brain works People with AUD may drink compulsively or feel like they cannot control their alcohol use Acamprosate is an FDA-approved drug that reduces anxiety and craving in some but not all people with AUD
Objective
To learn more about how acamprosate affects brain function in people with AUD
Eligibility
People aged 21 to 65 years with moderate to severe AUD
Design
Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days
Acamprosate is a capsule taken by mouth Half of participants will take this drug 3 times a day with meals The other half will take a placebo The placebo looks like the study drug but does not contain any medicine Participants will not know which capsules they are taking
Participants will have a procedure called electroencephalography EEG A gel will be applied to certain locations on their scalp and a snug cap will be placed on their head The cap has sensors with wires The sensors detect electrical activity in the brain Participants will lie still and perform 2 tasks they will look at different shapes and press a button when they see a specific one and they will listen to tones and press dedicated buttons when they hear the corresponding tones
Participants will have 2 EEGs 1 on day 2 and 1 on day 23 of their study participation They may opt to have up to 4 more EEG studies one on day 13 and one on each of the three follow-up visits and 2 sleep studies in which they would have sensors attached to their scalp while they sleep
Participants may have up to three follow-up visits for 6 months
Detailed Description:
Study Description
This double-blind placebo-controlled study will focus on electrophysiological changes in brains of alcohol use disorder AUDinpatients resulting from a post-withdrawal 21-day acamprosateplacebo treatment Known and established electroencephalogram EEG markers of AUD as well as anxiety and alcohol craving levels will be assessed pre- and post-treatment We hypothesize that acamprosate normalizes EEG markers associated with AUD beyond placebo specifically reduces beta power increases alpha power does not change slow band delta and theta power in resting EEG and reduces theta event-related synchronization ERS and amplifies and hastens P300 waveforms in event-related potentials ERPs
Objectives
Primary Objective To test via within-subject comparisons whether a 21-day acamprosate treatment regimen normalizes the EEG of AUD inpatients beyond placebo in reducing beta power increasing alpha power and changing slow band delta and theta power in resting EEG and reducing theta event-related synchronization ERS and amplifying and hastening P300 waveforms in event-related potentials ERPs
Secondary Objectives 1 To correlate EEG changes with clinical changes such as anxiety and alcohol craving 2 To determine polysomnographic markers of response to acamprosate 3 To correlate polysomnographic markers with clinical changes such as anxiety and alcohol craving
Endpoints
Primary Endpoint The said markers of EEG power and higher order EEG patterns will be measured before and after the 21-day treatment to compare the active-medication and placebo groups
Secondary Endpoints 1 Acamprosate-induced changes in EEG power and higher order EEG patterns will be correlated to changes in anxiety and alcohol craving 2 Acamprosate-induced changes in EEG power will be correlated to changes in polysomnographic markers such as total sleep time slow wave sleep duration sleep efficiency and total wake duration after sleep onset 3 Changes in polysomnographic markers will be correlated to changes in anxiety and alcohol craving
This double-blind placebo-controlled study will focus on electrophysiological changes in brains of alcohol use disorder AUDinpatients resulting from a post-withdrawal 21-day acamprosateplacebo treatment Known and established electroencephalogram EEG markers of AUD as well as anxiety and alcohol craving levels will be assessed pre- and post-treatment We hypothesize that acamprosate normalizes EEG markers associated with AUD beyond placebo specifically reduces beta power increases alpha power does not change slow band delta and theta power in resting EEG and reduces theta event-related synchronization ERS and amplifies and hastens P300 waveforms in event-related potentials ERPs
Objectives
Primary Objective To test via within-subject comparisons whether a 21-day acamprosate treatment regimen normalizes the EEG of AUD inpatients beyond placebo in reducing beta power increasing alpha power and changing slow band delta and theta power in resting EEG and reducing theta event-related synchronization ERS and amplifying and hastening P300 waveforms in event-related potentials ERPs
Secondary Objectives 1 To correlate EEG changes with clinical changes such as anxiety and alcohol craving 2 To determine polysomnographic markers of response to acamprosate 3 To correlate polysomnographic markers with clinical changes such as anxiety and alcohol craving
Endpoints
Primary Endpoint The said markers of EEG power and higher order EEG patterns will be measured before and after the 21-day treatment to compare the active-medication and placebo groups
Secondary Endpoints 1 Acamprosate-induced changes in EEG power and higher order EEG patterns will be correlated to changes in anxiety and alcohol craving 2 Acamprosate-induced changes in EEG power will be correlated to changes in polysomnographic markers such as total sleep time slow wave sleep duration sleep efficiency and total wake duration after sleep onset 3 Changes in polysomnographic markers will be correlated to changes in anxiety and alcohol craving
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 |
|---|---|---|---|
| 001644-AA | None | None | None |