A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Mean number of cigarettes smoked per day during the 21-day switching period.
研究概览
简要总结
The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products.
Participants will:
- Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks.
- Have 6 in-person research visits and 1 follow-up call
- Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use
详细描述
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 21 years old (i.e., able to legally purchase tobacco products)
- •able to read and communicate in English
- •no plans to quit smoking in the next 30 days
- •willing to stop using nicotine replacement or varenicline
- •willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
- •smoking ≥ 5 cigarettes per day for the past 6 months
- •exhaled carbon monoxide ≥ 6 ppm
- •no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months
排除标准
- •currently in treatment for psychosis or bipolar disorder
- •currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
- •currently pregnant or breastfeeding
研究组 & 干预措施
3mg Nicotine Pouches
Participants will use 3mg nicotine pouches
干预措施: Nicotine Pouches (Drug)
Nicotine Mini Lozenges
Participants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg)
干预措施: Mini Nicotine lozenges (Drug)
6mg Nicotine Pouches
Participants will use 6mg nicotine pouches
干预措施: Nicotine Pouches (Drug)
结局指标
主要结局
Mean number of cigarettes smoked per day during the 21-day switching period.
时间窗: Baseline to 3 weeks
Participants will self-report on their cigarette use
次要结局
- Change in cigarette craving(Baseline to 3 weeks)
- Mean units of study product used per day during the 7-days prior to the switching period(For 7-days leading up to the switching period)
- Mean units of study product used per day during the 21-day of the switching period(21-days of the switching period)