Electronic Nicotine Delivery Systems' Influence on Combustible Cigarette Smoking and Demand: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B) abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The investigators adapted a protocol used in a prior study to assign participants to switch to ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the investigators will provide all participants with ENDS pods during the study period and instruct them to only use ENDS provided by the study. Participants in reduced nicotine condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL) pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5% nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week. Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as usual.
详细描述
Background Use of Electronic Nicotine Delivery Systems (ENDS) has increased substantially in the past decade, and nearly 70% of ENDS users also smoke cigarettes (i.e., dual users). There is evidence that ENDS can be used as an effective smoking cessation aid. However, most dual users use ENDS intermittently, which does not appear to promote smoking cessation. ENDS use appears to be associated with increased overall nicotine addiction in some dual users and could perpetuate or increase combustible cigarette (CC) smoking. These concerns have contributed to policy changes to restrict ENDS use. For example the FDA's Center for Tobacco Products finalized a rule to regulate ENDS and could reduce the amount of nicotine in ENDS. Further, some states have begun to restrict access to ENDS. Market restrictions, FDA warning labels, and public education messaging have the potential to reduce ENDS consumption. Little is known, however, regarding the mechanisms of change in ENDS use that could affect nicotine addiction and CC smoking in dual users. Thus, the investigators are conducting a pilot randomized controlled trial (RCT) to test how change in ENDS nicotine (i.e. pharmacology) and change in frequency of ENDS use (i.e., behavior) affects nicotine addiction and CC smoking among dual users. Findings will inform understanding of how change in ENDS use contributes to nicotine addiction and how regulation that results in reduced nicotine consumption from ENDS could affect tobacco use among dual users.
Both pharmacological and behavioral factors contribute to nicotine dependence and thus could be mechanisms by which change in ENDS affects addiction among dual users. Prior research identified that switching to low nicotine CCs (i.e., change in pharmacology) and reduction in number of CCs (i.e., change in behavior) independently reduced nicotine dependence and demand for cigarettes within-participants over time. Similarly, observational data indicate that self-selected use of lower nicotine content ENDS (i.e., pharmacology) and less frequent vaping (i.e., behavior) appear to be associated with lower overall nicotine dependence among dual users. However, there is a lack of experimental research on whether change in ENDS nicotine content or frequency of use affects overall nicotine dependence among dual users.
Specific Aims
Primary Aim 1: To assess the feasibility of abruptly switching to low nicotine ENDS pods or abruptly reducing number of ENDS pods.
Aim 2: To assess the influence of switching to reduced nicotine ENDS compared to ENDS use as usual on CC smoking and nicotine dependence.
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
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Switch to low nicotine e-cigarettes
Switch to e-cigarettes containing 60% of baseline e-cigarette nicotine content.
干预措施: Nicotine (Drug)
Switch to low nicotine e-cigarettes
Switch to e-cigarettes containing 60% of baseline e-cigarette nicotine content.
干预措施: Juul e-cigarette (Device)
Reduce number of e-cigarette pods
Reduce e-cigarette use to 60% of baseline number of pods per week.
干预措施: Nicotine (Drug)
Reduce number of e-cigarette pods
Reduce e-cigarette use to 60% of baseline number of pods per week.
干预措施: Reduction (Behavioral)
结局指标
主要结局
Feasibility
时间窗: Baseline and the four week reduction period
The investigators will assess compliance with study e-cigarettes and compare the percent non-study e-cigarette use between conditions to determine which behavior-changing strategy is more feasible.
Combustible cigarette smoking
时间窗: Baseline and the four week reduction period
The investigators will compare change in number of cigarettes per day between conditions.
Cigarette dependence
时间窗: Baseline and the four week reduction period
The investigators will compare change in cigarette dependence between conditions using the PATH dependence measure.
E-cigarette dependence
时间窗: Baseline and the four week reduction period
The investigators will compare change in e-cigarette dependence between conditions using the PATH dependence measure.
次要结局
- Cigarette demand(Baseline and the four week reduction period)
- E-cigarette demand(Baseline and the four week reduction period)
研究者
Elias Klemperer
Professor
University of Vermont