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Minocycline's Effects on Alcohol Responses in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02187211
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : May 29, 2019
United States Department of Defense
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Minocycline Drug: Placebo (for Minocycline) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Minocycline's Effects on Alcohol Responses in Humans
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Minocycline Low Dose
Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
Drug: Minocycline
Experimental: Minocycline High Dose
Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
Drug: Minocycline
Placebo Comparator: Placebo
Participants in this arm will receive the Placebo for 10 days
Drug: Placebo (for Minocycline)

Primary Outcome Measures :
  1. Biphasic Alcohol Effects Scale (BAES) [ Time Frame: Days 1-10 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02187211

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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
United States Department of Defense
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Principal Investigator: Ismene Petrakis, M.D. Yale University

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Responsible Party: Yale University Identifier: NCT02187211    
Other Study ID Numbers: 1312013129
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Keywords provided by Yale University:
Alcohol Dependence
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Bacterial Agents