Nicotine Metabolism and Low Nicotine Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Smoking topography- total puff volume
研究概览
简要总结
This study examines the effects of smoking low nicotine cigarettes in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they break down and eliminate nicotine from their bodies more quickly. Other people are slower metabolizers meaning they break down and eliminate nicotine more slowly. The investigators are comparing these two groups of smokers for their responses to low nicotine cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine levels, and as a result continue to be exposed to significant toxin levels.
详细描述
This study examines the effects of smoking low nicotine cigarettes on smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current smokers (split between slow and rapid nicotine metabolizing smokers) for a 35-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. This application is designed to provide empirical science to inform the FDA on the effect smoking low nicotine content cigarettes will have on use patterns and harm exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
All subjects were blinded to the nicotine content of the study cigarettes.
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
- •adults age 21-
- •smoking at least 10 cigarettes per day.
- •smoking daily for the last 5 years.
- •Provide a baseline breath CO reading equal to or greater than 10 parts per million.
- •smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol).
- •not currently using any other nicotine containing products such as cigars, smokeless tobacco, nicotine replacement therapies (patch or gum).
- •are fluent in English and are capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- •Participants who meet the inclusion/exclusion criteria and attend an Intake Visit for medical screening will be asked to provide a blood sample to determine NMR. Only those individuals who are characterized as slow or rapid, based on NMRs ≤ .26, or ≥ .42, will be eligible.
排除标准
- •use of any nicotine containing products other than cigarettes
- •current or impending enrollment in smoking cessation program
- •history in the last year or current treatment of substance abuse (other than nicotine dependence)
- •positive drug screen for cocaine, methamphetamines or opiates for urine drug screen at intake session
- •alcohol use greater than 25 standard drinks per week
- •current or planned pregnancy or lactating
- •history or current diagnosis of psychosis, bipolar disorder, mania, or schizophrenia
- •current major depression (history of major depression but in remission for a minimum 6 months is eligible).
- •serious or unstable disease within past year (e.g. cancer other than melanoma, heart disease)
- •history or current diagnosis of COPD
- •history of stroke or heart attack
- •age less than 21 years- We wish to recruit smokers with well established smoking patterns and will restrict recruitment to those over 21
- •age more than 65 years - smoking is often associated with cardiovascular and pulmonary obstructive diseases that manifest later in life. As smokers develop these problems, smoking behavior and biomarkers of harm may be affected therefore we will restrict enrollment to those under age 65
- •provide baseline CO reading less than 10 at initial session
- •current use (or use within past 14 days) of any medication that affects the biotransformation of nicotine, such as anticonvulsant drugs, rifampin, and disulfiram; or any psychoactive medications which can affect smoking behaviors
- •any conditions viewed by the PI or study physician as creating a potential increased risk to a participant due to their participation will be reasons for exclusion
- •at the discretion of the PI, any participants viewed as non-compliant will be excluded from further participation
- •Smoke cigarettes with a filter size other than standard or slim sized as the topography mouthpieces are sized for standard filters and have an adapter for slim cigarettes only.
研究组 & 干预措施
Low nicotine cigarettes
Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
Other: Low nicotine cigarettes
干预措施: Low nicotine cigarettes (Other)
结局指标
主要结局
Smoking topography- total puff volume
时间窗: up to 35 days
次要结局
- Urine nicotine metabolite measures(Assessed at Days 5, 20 and 35)
- Daily cigarette consumption(Study day 0, 5, 10, 15, 20, 25, 30, 35)
- Carbon monoxide measurements(Study day 0, 5, 10, 15, 20, 25, 30, 35)
研究者
Andrew Strasser
Research associate professor
University of Pennsylvania