Neuroimmune Dysfunction in Alcohol Use Disorder
Alcohol Drinking, Alcohol-Related Disorders, Disease
About this trial
This is an interventional treatment trial for Alcohol Drinking focused on measuring Minocycline
Eligibility 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
Sites / Locations
- Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
AUD-Minocycline
AUD-Placebo
Healthy Control-Minocycline
Healthy Control-Placebo
Participants diagnosed with alcohol use disorder will be randomly assigned to take minocycline for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.
Participants diagnosed with alcohol use disorder will be randomly assigned to take placebo for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.
Healthy control participants will be randomly assigned to take minocycline for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.
Healthy control participants will be randomly assigned to take placebo for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.