Minocycline's Effects on Alcohol Responses in Humans

Yale University

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: Placebo (for Minocycline); Drug: Minocycline

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02187211

1312013129

1R21AA023150-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and females, between the ages of 21 and 50;
2. 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;
3. No current drug use disorder of any drugs of abuse (except alcohol and tobacco);
4. 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

1. Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
2. 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;
3. Liver function tests (ALT or AST) greater than 3 times normal;
4. Allergy to minocycline or other tetracyclines;
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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54 participants in 3 patient groups, including a placebo group

Minocycline Low Dose

Experimental group

Description:

Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days

Treatment:

Drug: Minocycline

Minocycline High Dose

Experimental group

Description:

Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days

Treatment:

Drug: Minocycline

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive the Placebo for 10 days

Treatment:

Drug: Placebo (for Minocycline)