NCT02187211

Minocycline's Effects on Alcohol Responses in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Minocycline
DRUG	Placebo (for Minocycline)

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2014-07-10
• Last updated: 2020-03-09

Locations

1 site across 1 country: United States