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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

Page last updated: August 23, 2015

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