Minocycline's Effects on Alcohol Responses in Humans
Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Yale University
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) United States Department of Defense