Communicating About Nicotine and Differential Risks of Tobacco Products in Priority Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,230
- 试验地点
- 4
- 主要终点
- Cigarettes per day
研究概览
简要总结
The goal of this clinical trial is to learn how a messaging campaign about reduced nicotine cigarettes and policy, combined with the use of very low nicotine cigarettes (VLNCs), affects smoking behavior and attitudes among adult smokers. The study also aims to assess the efficacy of the messages in different populations, including smokers with past-month serious psychological distress (SPD), low socioeconomic status (SES), and those in neither category.
The primary hypothesis is: exposure to messages in combination with VLNC use will lead to less cigarettes use compared to VLNCs without messages.
Researchers will compare: The effects of receiving VLNCs with messages (treatment group) to receiving VLNCs without messages (control group).
Participants will: Complete a baseline survey and be randomly assigned to one of two groups: treatment (VLNCs + messages) or control (VLNCs only). Attend weekly study visits for surveys, breath samples, and receive supply of VLNCs , either with or without the messaging campaign. Complete brief daily surveys through text messages.
详细描述
This is a randomized, open label, controlled, two-site study to test the efficacy of a messaging campaign about reduced nicotine cigarettes and policy in combination with the use of very low nicotine cigarettes (VLNCs). Smokers from three groups: with past-month serious psychological distress (SPD), with low socioeconomic status (SES), and in neither category will complete a 1-week baseline and a 4-week study; they will be randomized to one of two conditions:
- treatment condition, where participants receive VLNCs during weekly visits and are exposed to messages about VLNCs and reduced nicotine policy.
- control condition, where participants receive VLNCs without exposure to messages.
Message intervention: Messages about VLNCs and reduced nicotine policy will be professionally developed as full-color inserts (small leaflets that will be inserted into cigarette packs given to participants), print ads, and videos. At each weekly visit, participants will see 3-6 messages about VLNCs and reduced nicotine policy (in the treatment condition) or, in the control condition, 3-6 messages unrelated to tobacco (ads for bottled water, which are neutral messages that are unlikely to affect tobacco-related perceptions or behavior). Participants in the treatment conditions will also have inserts in their VLNC cigarette packs.
Baseline visit: Participants will complete a baseline survey, provide expired breath Carbon Monoxide (CO) sample, and receive a 1-week supply of the study cigarettes (full nicotine).
Randomization visit: Participants will be randomized into either the treatment (VLNCs + messages) or control (VLNCs only) condition. Participants will complete questionnaires, provide an expired CO sample, and receive a 14-day supply of VLNCs (either with or without the messages, according to the assigned condition).
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
- 是
入选标准
- •Age 21+ years
- •Current smoker (self-report as having smoked 100 cigarettes in their lifetime and currently smoking on 27+ days out of past 30, expired breath carbon monoxide [CO] ≥6ppm to assess regular smoking)
- •Can speak, read, and write in English
- •Available for period of study
- •Willing to try novel research cigarettes
排除标准
- •Pregnancy or lactation
- •Member of the same household as a study subject
- •Unwilling to use research cigarettes as part of the trial
结局指标
主要结局
Cigarettes per day
时间窗: Week 4 of the trial (post randomization)
Number of cigarettes smoked per day (study and non-study cigarettes). * Averaged number of cigarettes smoked based on 7 days' daily logs submitted through text-based survey during the last week of the trial. * Response: integer indicating number per day.
次要结局
- Use of other tobacco products(Week 4 of the trial (post randomization))
- Use of cessation medications(Week 4 of the trial (post randomization))
- Forgoing cigarettes(Through study completion, up to 4 weeks)
- Making a quit attempt(Through study completion, up to 4 weeks)
- Perceived risk of smoking VLNCs(Week 4 of the trial (post randomization))
- Self-efficacy to quit(Week 4 of the trial (post randomization))
- Intention to quit smoking(Week 4 of the trial (post randomization))
研究者
Lyudmila Popova
Associate Professor
Georgia State University