A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Alcohol Drinks Chosen
研究概览
简要总结
This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to speak/read English
- •not seeking treatment at the time of the study
- •one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
- •recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
- •ECG within normal limits
- •otherwise healthy
- •body mass index of 19-35
- •females using an effective form of birth control and not pregnant or breast feeding
- •judged by the medical staff to be psychiatrically and physically healthy
- •able to abstain from alcohol for 12 hours prior to session
- •no contraindications/allergies to n-acetylcysteine
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects will receive oral placebo capsules two times daily.
干预措施: Alcohol (Drug)
Placebo
Subjects will receive oral placebo capsules two times daily.
干预措施: Placebos (Drug)
Low Dose n-Acetylcysteine
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
干预措施: Alcohol (Drug)
Low Dose n-Acetylcysteine
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
干预措施: N-acetyl cysteine (Drug)
High Dose n-Acetylcysteine
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
干预措施: Alcohol (Drug)
High Dose n-Acetylcysteine
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
Number of Alcohol Drinks Chosen
时间窗: After at least four days of placebo or n-acetylcysteine maintenance
The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine.
次要结局
未报告次要终点
研究者
William Stoops
Professor
University of Kentucky