Minocycline's Effects on Alcohol Responses in Humans

Therapuetic Areas:Psychiatry / Psychology
Age Range:21 - 50
Start Date:July 2015
End Date:November 2018
Contact:Elizabeth Ralevski, Ph.D.
Phone:(203) 932-5711

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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

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.
We found this trial at
950 Campbell Ave
West Haven, Connecticut 06516
(203) 932-5711
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
West Haven, CT
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