Minocycline's Effects on Alcohol Responses in Humans
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Minocycline Low Dose Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days |
Drug: Minocycline
|
| Experimental: Minocycline High Dose Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days |
Drug: Minocycline
|
| Placebo Comparator: Placebo Participants in this arm will receive the Placebo for 10 days |
Drug: Placebo (for Minocycline)
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and females, between the ages of 21 and 50;
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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;
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No current drug use disorder of any drugs of abuse (except alcohol and tobacco);
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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:
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Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
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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;
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Liver function tests (ALT or AST) greater than 3 times normal;
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Allergy to minocycline or other tetracyclines;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Connecticut Healthcare System | West Haven | Connecticut | United States | 06516 |
Sponsors and Collaborators
- Yale University
- United States Department of Defense
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Ismene Petrakis, M.D., Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1312013129
- 1R21AA023150-01A1