Neuroimmune Dysfunction in Alcohol Use Disorder

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    72
  • sponsor
    University of Maryland, Baltimore
Updated on 20 March 2021
minocycline
heavy drinking
alcohol use disorder

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.

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.

Details
Condition Disease, Drinking Behavior, Anti-Infective Agents, Psychosis, Drug abuse, Mental illness, Alcohol use, pathological process, Alcohol-Related Disorders, Inflammation, Minocycline, Antibiotic, Cognitive Disorder, Alcohol abuse, Alcohol Use Disorder, Cognitive Impairment, Cognitive Dysfunction, Neurocognitive Disorders, Cognitive Deficits, Psychological Disorders, Neurocognitive Disorder, Cognitive Deficit, Cognitive Impairments, Substance Abuse, Drug use, Alcohol Dependence, Chemically-Induced Disorders, Chemically-Induced Disorders, alcohol related disorders, alcoholism, pathological processes, psychiatric disorder, psychiatric illness, mental disorder, psychiatric disorders, mental disorders, psychological disorder, psychiatric diseases, psychiatric disease, mental disease, anti-infectives, anti-infective, anti-infective agent, antiinfective, attention disorders, cognition disorders, cognitive disorders, disorder attention, alcohol dependence syndrome, chronic alcoholism, pathologic processes, pathologic process, neurocognitive disturbance, psychotic disorders, psychotic, psychotic disorder, antibacterial, antibacterial agents, antibacterials, antibacterial agent, antibacterial drugs, other disease, disease or disorder, Chemically-Induced Disorders, Chemically-Induced Disorders, Chemically-Induced Disorders
Treatment sugar pill, Minocycline
Clinical Study IdentifierNCT04210713
SponsorUniversity of Maryland, Baltimore
Last Modified on20 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do not meet DSM-5 diagnostic criteria for an AUD (current or lifetime)
In the 30-day period before enrollment, consume 14 and 7 standard drinks per week for men and women, respectively
Engage in infrequent heavy drinking during the past 6 months ( 2 heavy drinking events in past 6 months)

Exclusion Criteria

Lifetime DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine
Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive disorders, anxiety disorders (panic disorder, agoraphobia, social anxiety, and generalized anxiety), obsessive-compulsive and related disorders, trauma- and stressor-related disorders, feeding and eating disorders (binge eating, anorexia, and bulimia), conduct disorders, and gambling disorder
Self-described daily cannabis user
Positive urine toxicology screen for illicit substances (excluding marijuana)
If female: pregnancy, nursing, or refusal to use reliable method of birth control; if using hormonal contraceptives, refusal to use secondary birth control method
A medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
AST, ALT, or GGT 3 times upper normal limit
Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year
Currently on prescription medication that contraindicates use of minocycline
Previously known hypersensitivity to tetracyclines
Current or recent (within one month) treatment with tetracycline, tetracycline derivative, or any other antibiotic
Claustrophobia or physical issues preventing MRI scan
Presence of a metal device in the body (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate)
Current or recent (within 3 months) participation in a clinical trial involving medication administration
History of traumatic brain injury
Having below a 6th grade reading level
Within the last 3 months, tested positive for COVID-19 (i.e. the SARS-CoV-2 virus) and experienced common related symptoms
Any other circumstances that, in the opinion of the investigators, compromises participant safety
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