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Minocycline's Effects on Alcohol Responses in Humans

Phase 1
Completed
Conditions
Alcohol Dependence
Interventions
Drug: Placebo (for Minocycline)
Drug: Minocycline
Registration Number
NCT02187211
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo (for Minocycline)Participants in this arm will receive the Placebo for 10 days
Minocycline Low DoseMinocyclineParticipants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
Minocycline High DoseMinocyclineParticipants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
Primary Outcome Measures
NameTimeMethod
Biphasic Alcohol Effects Scale (BAES)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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

VA Connecticut Healthcare System

🇺🇸

West Haven, Connecticut, United States

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