Assessment of Smoking Topography and Behaviors During Response to Varenicline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Smoking Topography: Total Puff Volume
研究概览
简要总结
This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.
详细描述
This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self report minimum 10 daily cigarettes
- •self report smoking every day past 5 years
- •between the ages 21-65
- •self report intention to try to quit smoking in the next 6 months
排除标准
- •self reported use of any nicotine-containing products other than non-menthol cigarettes
- •self reported history or current treatment of substance abuse (other than nicotine dependence)
- •self reported alcohol use greater than 25 standard drinks per week;
- •currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
- •self reported history or current diagnosis of any Axis 1 disorders except past depression
- •self reported serious or unstable disease within past year
- •self reported history of epilepsy or seizure disorder;
- •self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
- •self reported kidney function impairment
- •any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
- •less than 5 years of daily smoking
- •any medical condition or concomitant medication that could compromise participant safety or treatment
- •provide a baseline carbon monoxide (CO) reading < 10 ppm
- •self reported use of non filtered cigarettes
- •inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
研究组 & 干预措施
Varenicline before placebo
Drug (Varenicline (Chantix)): Placebo
Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
干预措施: Varenicline (Drug)
Placebo then Varenicline
Placebo: Drug Varenicline (Chantix)
Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Intervention 'Drug (Varenicline (Chantix)): Placebo'
干预措施: Varenicline (Drug)
结局指标
主要结局
Smoking Topography: Total Puff Volume
时间窗: Days 1-21 of each of 2 study periods
Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.
The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
时间窗: Days 1, 7, 21 of each of two 21 day study periods
Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.
Daily Cigarette Consumption
时间窗: Two 21 day study periods
Average of the number of cigarettes smoked per day
次要结局
- Total Nicotine Metabolites From Urine Samples(Samples from Day 1 and Day 21 of two 21 day Periods)
- Carbon Monoxide Levels(Samples from Day 1 and Day 21 of two 21 day Periods)
- Subjective Measures to Assess Smoking Urges(Days 21 of each of the two 21-day study periods, range 1(low)-7(high))
- Nicotine Levels From Urine Samples(Samples from Day 1 and Day 21 of two 21 day Periods)
- Cotinine Levels From Urine Samples(Samples from Day 1 and Day 21 of two 21 day Periods)
研究者
Andrew Strasser
Associate Professor Department of Psychiatry
University of Pennsylvania