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临床试验/NCT06373679
NCT06373679招募中不适用

Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2024年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
2
主要终点
Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback

研究概览

简要总结

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

详细描述

Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking.

These data are urgently needed for several reasons.

  1. Clinicians cannot provide clear guidance to smokers who may be interested in switching. Questions from medical patients about e-cigarettes are on the rise, and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes, with some physicians discouraging their use and some recommending them as cessation aids.
  2. Public health organizations are also providing mixed messages about the health risks of non-cigarette tobacco products-with some not recommending their use at all (The American Cancer Society, American Lung Association), and some acknowledging that complete switching to e-cigarettes would reduce health risks compared to continued smoking, but not recommending the use of these products over traditional methods (Centers for Disease Control, Food and Drug Administration).
  3. In the absence of clear messaging about non-cigarette products, smokers who fail with traditional methods are continuing to smoke cigarettes, the most harmful tobacco product available.

The reviews underscore the need for additional data on this topic, especially data comparing the products to pharmacotherapy. The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products (e-cigarettes) have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.
  • Interest in reducing harms from tobacco use or quitting smoking

排除标准

  • Pregnant, breastfeeding, or trying to become pregnant.
  • Household member currently enrolled in the study
  • Planning to move out of the area within the next 7 months

研究组 & 干预措施

Choice of Medication

Experimental

This arm includes participants randomly assigned to the Meds Group. Participants will choose between 1) combo NRT and 2) varenicline. The NRT will consist of transdermal NRT and nicotine lozenge. Participants will receive study product for 11 weeks.

干预措施: Switching using Medication (Behavioral)

Choice of E-Cigarette

Experimental

This arm includes participants randomly assigned to the E-Cigarette Group. Participants will choose between two different brands of e-cigarettes and choose up to two different flavors. Participants will receive study product for 11 weeks.

干预措施: Switching to E-Cigarette (Behavioral)

结局指标

主要结局

Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback

时间窗: 11 Weeks

Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide \< 6 ppm

次要结局

  • Greater than 50% reduction in cigarette smoking(11 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tracy Smith

Professor-Faculty

Medical University of South Carolina

研究点 (2)

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