Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04210713
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2019-12-17
Brief Title:
Neuroimmune Dysfunction in Alcohol Use Disorder
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Characterization of Neuroimmune Dysfunction in Alcohol Use Disorder
Status:
COMPLETED
Status Verified Date:
2023-11
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:
The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline a neuroimmune modulator as a potential treatment This study has important clinical implications as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority
Detailed Description:
The research objective of this project is to characterize the role of the neuroimmune system in alcohol use disorder AUD The proposed study employs a randomized double-blind and placebo-controlled design to examine how neuroinflammation as measured via neuroimaging eg magnetic resonance imaging MRI relates to alcohol craving neurocognitive impairment eg memory attention etc and alcohol use in non-treatment seeking individuals with AUD The study will also determine whether minocycline MINO an FDA-approved antibiotic medication affects any of the above listed measures In the proposed study healthy controls n 36 and non-treatment seeking individuals with a current Diagnostic and Statistical Manual of Mental Disorders DSM-5 AUD diagnosis n 36 will be randomized to receive either 200 mg of minocycline per day or placebo for approximately 28 days and complete two laboratory sessions The first laboratory session will be performed immediately before commencing the medication regimen day 0 and the second will be completed after taking the medication daily for approximately 28 days Within each laboratory session participants will complete a cue reactivity paradigm neurocognitive performance tasks and a magnetic resonance imaging MRI session Additionally blood samples will be drawn on days 0 7 14 21 and 28 of treatment to measure circulating levels of proinflammatory molecules in order to identify the specific immune signaling pathways underlying neuroinflammation in AUD Clinical labs eg blood chemistry liver function tests and adverse events AEs will also be assessed at these five visits
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K01AA026005-03 | NIH | None | httpsreporternihgovquickSearch5K01AA026005-03 |