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Minocycline's Effects on Alcohol Responses in Humans

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Placebo (for Minocycline)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, Minocycline

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Minocycline Low Dose

Minocycline High Dose

Placebo

Arm Description

Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days

Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days

Participants in this arm will receive the Placebo for 10 days

Outcomes

Primary Outcome Measures

Biphasic Alcohol Effects Scale (BAES)
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

Full Information

First Posted
July 8, 2014
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
United States Department of Defense, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02187211
Brief Title
Minocycline's Effects on Alcohol Responses in Humans
Official Title
Minocycline's Effects on Alcohol Responses in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
United States Department of Defense, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol Dependence, Minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline Low Dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
Arm Title
Minocycline High Dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive the Placebo for 10 days
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Type
Drug
Intervention Name(s)
Placebo (for Minocycline)
Primary Outcome Measure Information:
Title
Biphasic Alcohol Effects Scale (BAES)
Description
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
Time Frame
Days 1-10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismene Petrakis, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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Minocycline's Effects on Alcohol Responses in Humans

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