Minocycline's Effects on Alcohol Responses in Humans

NCT ID: NCT02187211

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2018-11-01

Brief Summary

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Minocycline Low Dose

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

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

Minocycline High Dose

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

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

Placebo

Participants in this arm will receive the Placebo for 10 days

Group Type: PLACEBO_COMPARATOR

Placebo (for Minocycline)

Intervention Type: DRUG

Interventions

Minocycline

Intervention Type: DRUG

Placebo (for Minocycline)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismene Petrakis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R21AA023150-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1312013129

Identifier Type: -

Identifier Source: org_study_id