Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Cigarettes Smoked Per Day (Log-transformed)
研究概览
简要总结
This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
- •English literate
- •Smoke at least 1 cigarette per day
- •Expired breath carbon monoxide level ≥ 6ppm at baseline
- •Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month
- •Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).
排除标准
- •Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
- •History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
- •Current uncontrolled medical condition
- •Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)
- •Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study
- •Severe lung disease that requires supplemental oxygen
- •Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
- •Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
- •Planning to quit smoking with a set goal or time for quit attempt
- •Known hypersensitivity to propylene glycol
- •Patients with an FEV1 < 40%
结局指标
主要结局
Number of Cigarettes Smoked Per Day (Log-transformed)
时间窗: up to week 4
The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.
次要结局
- Subjective Effects of Oral Nicotine Pouches(week 4)
- Level of Biomarker (NNAL) Among Smokers(baseline and week 4)
- Percentage of Smoke Free Days.(up to week 4)
- Number of Participants Who Switched From Cigarettes to the ZYN Pouches.(This will be evaluated at week 4.)