Neuroimmune Dysfunction in Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Minocycline

Criteria

AUD Group Inclusion Criteria:

• Meet DSM-5 diagnostic criteria for an AUD

• In the 30-day period before enrollment, consume ≥ 14 and ≥ 7 standard drinks per week for men and women, respectively, AND

• In the 30-day period before enrollment, engage in heavy drinking ≥ 1 times per week (5 or more drinks for men, 4 or more drinks for women) and ≥ 5 times per month

AUD Group Exclusion Criteria:

• Currently in treatment for AUD, a history of treatment within the 30 days before enrollment, or currently seeking immediate treatment

• Current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine

• Self-described daily cannabis user

• Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders and bipolar and related disorders

• Positive urine toxicology screen for illicit substances (excluding marijuana)

• Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised

• 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)

• alanine aminotransferase (ALT), aspartate aminotransferase (AST), or γ-glutamyl transferase (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

Healthy Control Group 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)

Healthy Control Group 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