NCT04210713

Neuroimmune Dysfunction in Alcohol Use Disorder

Characterization of Neuroimmune Dysfunction in Alcohol Use Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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 \[e.g., magnetic resonance imaging (MRI)\], relates to alcohol craving, neurocognitive impairment (e.g., 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 (e.g., blood chemistry, liver function tests) and adverse events (AEs) will also be assessed at these five visits.

Conditions

• Alcohol Drinking
• Alcohol-Related Disorders
• Disease
• Inflammation
• Alcoholism
• Cognitive Dysfunction
• Pathologic Processes
• Drinking Behavior
• Substance-Related Disorders
• Chemically-Induced Disorders
• Mental Disorder
• Cognition Disorder
• Neurocognitive Disorders
• Minocycline
• Anti-Bacterial Agents
• Anti-Infective Agents

Interventions

Type	Name	Description
DRUG	Minocycline	200 mg/day
DRUG	Sugar pill	Matched placebo

Timeline

• Start date: 2020-02-03
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2019-12-26
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study