Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Subjective Responses to Intravenous Nicotine
研究概览
简要总结
To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.
详细描述
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male smokers, aged 18 to 55 years
- •History of smoking daily for the past 12 months, at least 15 cigarettes daily
- •Carbon Monoxide (Alveolar) level > 10ppm
- •For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods
排除标准
- •History of heart disease, renal or hepatic diseases
- •other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study
- •Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- •recent psychiatric diagnosis and treatment for Axis I disorders including
- •major depression, bipolar affective disorder,
- •schizophrenia and panic disorder within the past year
- •Current dependence on alcohol
- •drugs or treatments for drug
- •alcohol addiction within the past 5 years
- •Allergy to varenicline
研究组 & 干预措施
Placebo First, varenicline, + IV Nic
Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg).
干预措施: Varenicline (Drug)
Placebo First, varenicline, + IV Nic
Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg).
干预措施: Placebo (Drug)
Placebo First, varenicline, + IV Nic
Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg).
干预措施: IV Nic (Drug)
Varenicline first, placebo, + IV Nic
Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).
干预措施: Varenicline (Drug)
Varenicline first, placebo, + IV Nic
Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).
干预措施: Placebo (Drug)
Varenicline first, placebo, + IV Nic
Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).
干预措施: IV Nic (Drug)
结局指标
主要结局
Subjective Responses to Intravenous Nicotine
时间窗: 30 minutes after each nicotine infusion
The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.
次要结局
- Mean Reaction Time (RT) on Modified Stroop Task.(pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine))
- Heart Rate(30 minutes after each nicotine infusion)
- Changes in Systolic and Diastolic Blood Pressure(30 minutes after each nicotine infusion)
- Cotinine Levels(Before each laboratory session on day 5)