A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Alcohol Craving
研究概览
简要总结
This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact that it targets NET, neither of which has heretofore been examined in the context of alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will provide the PI with sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and the involvement of specific single nucleotide polymorphisms within the NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term objective of this research is to develop more efficacious treatment interventions for alcohol abuse and dependence.
Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who receive a placebo.
Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication) than subjects who receive a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sugar Pill
干预措施: Atomoxetine, Strattera (Drug)
Atomoxetine 40 mg
干预措施: Atomoxetine, Strattera (Drug)
Atomoxetine 60 mg
干预措施: Atomoxetine, Strattera (Drug)
Atomoxetine 80 mg
干预措施: Atomoxetine, Strattera (Drug)
结局指标
主要结局
Alcohol Craving
时间窗: Day 5 of medication
Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS
次要结局
- Genetic moderation(day 5 of medication)
