Impact of Low Nicotine Cigarette Messaging on Risk Perceptions and Hypothetical Tobacco and Nicotine Product Choices.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proportion of participants that choose ANDS or no tobacco
研究概览
简要总结
The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.
详细描述
This randomized single-site study will assess the subject's risk perceptions and hypothetical tobacco product choices based on their exposure to an educational messaging condition related to nicotine content in cigarettes.
Subjects (N=40 in each group) will be given a pack of low nicotine content cigarettes (LNC; 0.4 mg/g) and will be randomly assigned to read one of two messaging conditions on low nicotine cigarettes.
Smokers will undergo a telephone screening to assess eligibility, then move on to the next steps of the study depending on eligibility:
- Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed.
- Curbside Visit - Completed after the screening and if eligible: Breath test, and if necessary a urine test, is performed to assess smoking levels and urine pregnancy test is attained (if applicable). If eligible, randomization to messaging condition occurs and participants provided a pack of low nicotine content cigarettes.
- Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed.
- Follow-up - Completed 1 week after the virtual Zoom session: Interview where assessment of health and product usage is assessed.
Except for the initial telephone screening, participants will receive compensation for each part of the study.
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
- •Male or female
- •At least 21 years of age
- •Biochemically confirmed smoker
排除标准
- •Unstable health condition
- •Unstable medications
- •Pregnant or nursing
- •Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires
研究组 & 干预措施
Control message on low nicotine cigarettes
干预措施: Low Nicotine Content Cigarettes (Drug)
Control message on low nicotine cigarettes
干预措施: Control message (Other)
Test message on low nicotine cigarettes
干预措施: Low Nicotine Content Cigarettes (Drug)
Test message on low nicotine cigarettes
干预措施: Test message (Other)
结局指标
主要结局
Proportion of participants that choose ANDS or no tobacco
时间窗: Within 17 days of virtual screening
Proportion of participants who select to use ANDS or no tobacco if LNC cigarettes were the only cigarettes available will be compared in arm 1 versus arm 2
次要结局
未报告次要终点
