Status:
COMPLETED
Minocycline's Effects on Alcohol Responses in Humans
Lead Sponsor:
Yale University
Collaborating Sponsors:
United States Department of Defense
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02187211
Start Date
July 1 2015
End Date
November 1 2018
Last Update
March 9 2020
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516