Clinical trial NCT02187211: Minocycline's Effects on Alcohol Responses in Humans
Official title: Minocycline's Effects on Alcohol Responses in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence
Minocycline
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-07-10
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Biphasic Alcohol Effects Scale (BAES)
timeFrame: Days 1-10
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Ismene Petrakis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: