Addiction Potential of Very Low Nicotine Filtered Little Cigars
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Drug self-administration- Puff topography- total puff volume
研究概览
简要总结
The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question[s] it aims to answer are:
Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars?
Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will
- fill several surveys
- provide blood samples
- perform breathing tests
- complete smoking sessions using either their own cigars or the study cigars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as >=8 cigars smoked per month based on data showing median cigarillo use is 7.5 times per month and median FLC use is 14 times per month
- •We will attempt to bring in heavier users if feasible during recruitment; or 2) Cigarette smokers (>=8d/month for at least 3 months) with either (i) co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in their lifetime) or (ii) answering "yes" to the question "If all cigarettes were taken off the market, would you consider switching to filtered little cigars?"
- •willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- •Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit
- •capable of and willing to provide written informed consent
- •read and speak in English.
排除标准
- •Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed
- •History of diagnosis or treatment for lung cancer
- •Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
- •History of cardiac event or distress within the past 3 months
- •Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- •Substance use disorders besides nicotine addiction
- •Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes >10d per month
- •Exclusive large or premium cigar users
- •Use of blunts every time or most of the time
- •Regular use of cannabis >10d per month
- •Planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days
- •Pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant
- •Inability to perform tests or follow instructions during testing
研究组 & 干预措施
Smoking session
All participants will undergo three smoking sessions: one using their own usual brand cigar, one with a normal nicotine study cigar, and one with a reduced nicotine study cigar
干预措施: Reduced Nicotine Content Cigars (Drug)
Smoking session
All participants will undergo three smoking sessions: one using their own usual brand cigar, one with a normal nicotine study cigar, and one with a reduced nicotine study cigar
干预措施: Normal nicotine content cigar (Drug)
Smoking session
All participants will undergo three smoking sessions: one using their own usual brand cigar, one with a normal nicotine study cigar, and one with a reduced nicotine study cigar
干预措施: Usual brand cigar (Drug)
结局指标
主要结局
Drug self-administration- Puff topography- total puff volume
时间窗: During session 65 minute puffing session
Derived from puff topography, total puff volume indicates the total amount of smoke inhaled during the smoking session. Units: mL
Forced expiratory volume in 1 second
时间窗: Change from 0 to 65 minutes
Spirometry will be completed before and after a 65 min smoking session
Nicotine
时间窗: Change from 0 to 65 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 65 minutes after the smoking session
Carbon monoxide boost
时间窗: Change from 0 to 65 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and after the smoking session
次要结局
- Functional residual capacity(Change from 0 to 65 minutes)
- Airway resistance (R5)(Change from 0 to 65 minutes)
- Airway resistance (R5-R20)(Change from 0 to 65 minutes)
- Modified Cigarette Evaluation Scale(65 minutes)
- Questionnaire on Smoking Urges (Tiffany Drobes)(Change from 0 to 65 minutes)
- Minnesota Nicotine Withdrawal Scale(Change from 0 to 65 minutes)
- Hypothetical purchase task(65 minutes)
- Cross-price task(65 minutes)
研究者
Dharini Bhammar
Assistant Professor
Ohio State University Comprehensive Cancer Center