Minocycline's Effects on Alcohol Responses in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Biphasic Alcohol Effects Scale (BAES)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females, between the ages of 21 and 50;
- •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;
- •No current drug use disorder of any drugs of abuse (except alcohol and tobacco);
- •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.
排除标准
- •Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
- •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;
- •Liver function tests (ALT or AST) greater than 3 times normal;
- •Allergy to minocycline or other tetracyclines;
- •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.
研究组 & 干预措施
Minocycline Low Dose
Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
干预措施: Minocycline (Drug)
Minocycline High Dose
Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
干预措施: Minocycline (Drug)
Placebo
Participants in this arm will receive the Placebo for 10 days
干预措施: Placebo (for Minocycline) (Drug)
结局指标
主要结局
Biphasic Alcohol Effects Scale (BAES)
时间窗: 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
次要结局
未报告次要终点