Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Rapid Visual Information Processing
研究概览
简要总结
The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.
详细描述
This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures.
To date this study has 35 completers and currently in data analysis. (January 2016)
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
- Double (Participant, 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;
- •No current dependence or abuse of drugs of abuse or alcohol (except and tobacco);
- •No current medical problems and normal ECG;
- •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, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
- •Known allergy to Atomoxetine;
- •Use of Monoamine Oxidase inhibitor within the last month (clinically Atomoxetine administration is contraindicated with or within 2 weeks of discontinuation of Monoamine oxidase inhibitor therapy).
研究组 & 干预措施
Atomoxetine
Atomoxetine compared to the sugar pill
干预措施: Sugar Pill (Drug)
Sugar Pill
Sugar pill compared to atomoxetine
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Rapid Visual Information Processing
时间窗: 2 years
Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.
Rapid Visual Information Processing: Mean Correct Response Latency
时间窗: 2 years
Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
Prinicipal Investigator
Yale University