A Randomized Trial to Compare Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
研究概览
简要总结
The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the most common method for smokers to reduce their nicotine intake is to reduce their number of cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or quitting; thus the investigators will examine the two strategies by randomizing smokers to 1) switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine patch to help them reduce their nicotine intake.
详细描述
Primary:
- Determine the relative feasibility of switching to VLNC cigarettes vs reducing CPD when all participants are aided by nicotine replacement therapy (NRT).
- Determine whether switching to VLNC cigarettes or reducing CPD more effectively reduces nicotine dependence when all participants are aided by NRT.
Secondary: 3. Determine whether switching to VLNC cigarettes vs reducing CPD increases quit attempts and 7-day point-prevalence abstinence more when all participants are aided by NRT. 4. Determine the relative effectiveness of switching to VLNC cigarettes and reducing CPD when all participants are aided by NRT with comparisons of a) craving, b) withdrawal, c) perceived harm from smoking and d) participants' enjoyment from smoking. 5. Determine whether switching to VLNC cigarettes or reducing CPD increases use of e-cigarettes or other non-combustible nicotine products more.
Rationale for Proposed Study:
A policy to reduce the nicotine content of cigarettes could be useful for the majority of smokers who are not ready to quit. Specifically, the FDA recently gained the authority to regulate cigarettes' nicotine content and switching to very low nicotine content (VLNC) cigarettes has been proposed as a future regulatory policy to give smokers the option to decrease nicotine intake from cigarettes in order to decrease nicotine dependence and quit smoking. A review of clinical trials suggest that switching to VLNC cigarettes with and without nicotine replacement therapy (NRT) reduces dependence, carcinogens, and carbon monoxide and increases quitting; however, its long-term effects are unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility will be determined based on:
- •participants' age,
- •their cigarettes smoked per day,
- •their intention to quit,
- •their willingness to use medications,
- •prior use of tobacco and non-tobacco nicotine products,
- •prior use of stop-smoking services or medications,
- •DSM 5 criteria for Tobacco Use Disorder,
- •current use of opioid maintenance medications,
- •access to a telephone and the Internet,
- •proximity to the University of Vermont,
- •their bed time,
- •status as a US citizen,
- •comfort speaking, reading and writing in English, and
- •whether or not the participant is breast feeding, pregnant or has the potential to become pregnant or begin breastfeeding during the study period.
排除标准
- 未提供
研究组 & 干预措施
Switch to VLNC cigarettes
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
干预措施: Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) (Other)
Reduce CPD
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
干预措施: Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT) (Other)
结局指标
主要结局
Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
时间窗: Assessed weekly during the 4 week reduction period after the baseline week
The investigators will use non-adherence to nicotine reduction (i.e., self report of percent non-study cigarettes per day) as an indicator of feasibility.
Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)
时间窗: Assessed weekly during the 4 week reduction period after the baseline week
The NDSS is a measure of dependence that does not rely on cigarettes per day as an indicator of dependence.
次要结局
- Number of Participants With Self Reported Seven Day Point Prevalence Abstinence(Assessed at the end of the 4 week reduction period)
- Any Quit Attempt (QA)(Participants were asked at the end of the reduction period whether they made a quit attempt at any point during the 4 week reduction period.)
- Self-efficacy to Quit Smoking(Week 0 - Week 4)
研究者
Elias Klemperer
Predoctoral Trainee
University of Vermont