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临床试验/NCT04740008
NCT04740008已完成早期 1 期

Impact of Low Nicotine Cigarette Messaging on Risk Perceptions and Hypothetical Tobacco and Nicotine Product Choices.

Masonic Cancer Center, University of Minnesota1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年4月20日最近更新:
适应症
干预措施
相关药物

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:

  1. Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed.
  2. 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.
  3. Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed.
  4. 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

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

Experimental

干预措施: Low Nicotine Content Cigarettes (Drug)

Control message on low nicotine cigarettes

Experimental

干预措施: Control message (Other)

Test message on low nicotine cigarettes

Experimental

干预措施: Low Nicotine Content Cigarettes (Drug)

Test message on low nicotine cigarettes

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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