Minocycline's Effects on Alcohol Responses in Humans
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence
Intervention: Minocycline (Drug); Placebo (for Minocycline) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s): Ismene Petrakis, M.D., Principal Investigator, Affiliation: Yale University
Overall contact: Elizabeth Ralevski, Ph.D., Phone: (203) 932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu
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.
Clinical Details
Official title: Minocycline's Effects on Alcohol Responses in Humans
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Biphasic Alcohol Effects Scale (BAES)
Eligibility
Minimum age: 21 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Elizabeth Ralevski, Ph.D., Phone: (203) 932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu
VA Connecticut Healthcare System, West Haven, Connecticut 06516, United States; Recruiting Elizabeth Ralevski, Ph.D., Phone: 203-932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu
Additional Information
Starting date: July 2015
Last updated: July 14, 2015
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