试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine
研究概览
简要总结
A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
详细描述
This pilot study will examine the effects of a norepinephrine reuptake blocker, atomoxetine, on physiological and subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. The physical stress model will be the cold pressor test (CPT) and the psychological stress will be the paced auditory serial addition task (PASAT).
Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine.
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Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.
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Methodology: A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
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Findings: Since our last renewal, a total of 16 subjects signed the consent form. Among those, 6 subjects did not return after signing the consent form. An additional 2 subjects were randomized but did not complete the study. One subjects started 3 times was randomized 3 times therefore counted three times in enrollment. Currently still enrolling subjects. (2/7/07)
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and males age 18 yrs to 45 yrs
- •Current history of good health and normal ECG
- •not pregnant , nor breast feeding
- •using acceptable birth control methods
排除标准
- •History of heart disease, hypertension, renal or hepatic diseases, glaucoma,hyperthyroidism,
- •Current use of psychotropic medication
- •Current dependence on alcohol or on drugs or treatments for drug or alcohol addiction within the past 5 years
研究组 & 干预措施
1
atomoxetine 40mg per day
干预措施: Atomoxetine (Drug)
2
second arm is placebo, sugar pill
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine
时间窗: one year
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
Principle Investigator
Yale University