Minocycline's Effects on Alcohol Responses in Humans

Alcohol Dependence Clinical Trial

Official title:

Minocycline's Effects on Alcohol Responses in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187211
• Other study ID #: 1312013129
• Secondary ID: 1R21AA023150-01A
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2015
• Est. completion date: November 1, 2018

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Minocycline

• Placebo (for Minocycline)

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days 1-10