Minocycline's Effects on Alcohol Responses in Humans

Study Overview
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Brief Summary
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This is a double-blind, placebo-controlled, outpatient study with a between-groups design. Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or 400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3 outpatient visits for medication administration, dispensing of take-home doses and monitoring of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will have 2 laboratory sessions where alcohol or placebo will be administered intravenously using a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc) method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple outcome measures including subjective, motor, cognitive measurement and plasma cytokine levels.

Official Title
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Minocycline's Effects on Alcohol Responses in Humans

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Minocycline
* Drug: Placebo (for Minocycline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females, between the ages of 21 and 50; Heavy social drinkers who are defined as consuming ≥10 standard alcoholic drinks per week with one to five weekly binge drinking episodes, (5 plus drinks per occasion for men; 4 plus drinks for women). No maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for AUD will be excluded from the study; No current drug use disorder of any drugs of abuse (except alcohol and tobacco); No current medical problems and normal ECG; 5) For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods. Exclusion Criteria: Current major psychiatric illnesses including mood, psychotic, or anxiety disorders; History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study; Liver function tests (ALT or AST) greater than 3 times normal; Allergy to minocycline or other tetracyclines; Participants who at any appointment have a Clinical Institute Withdrawal Assessment Scale (CIWA) [36, 37] score of 4 or greater, or who report any history of alcohol withdrawal within the past 6 months.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline Low Dose<br>Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days | Drug: Minocycline<br> <br> |
| Experimental: Minocycline High Dose<br>Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days | Drug: Minocycline<br> <br> |
| Placebo Comparator: Placebo<br>Participants in this arm will receive the Placebo for 10 days | Drug: Placebo (for Minocycline)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biphasic Alcohol Effects Scale (BAES) | BAES will be used to measure the stimulant and sedative effects of alcohol during the test sessions. This instrument has been found to be a sensitive and reliable measure to study medication influences on alcohol effects | Days 1-10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Minocycline