Effects of Labetalol on Nicotine Administration in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Subjective
研究概览
简要总结
The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine
详细描述
The purpose of this study is to determine whether labetalol, an alpha and beta adrenergic blocker, will block the subjective and physiological effects of intravenously administered nicotine in humans. A total of 12 subjects will participate in the double blind placebo controlled, outpatient study. Subjects will have 3 separate experimental sessions 3-9 days apart. On each of the experimental sessions, a single oral dose of low (100mg) or high dose of labetalol (200mg ), or placebo will be administered. Two hours after labetalol or placebo treatment, subjects will receive 15 variance grams nicotine base/kg intravenously. Several physiological endocrine and subjective measures will be obtained during the sessions. We propose that blockage of adrenergic receptors by labetalol will significantly block the physological and subjective effects of nicotine.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests.
排除标准
- •History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products.
结局指标
主要结局
Subjective
Physiologic measures
次要结局
未报告次要终点
