NCT05076708已完成早期 1 期
The Effects of IQOS Use on Cigarette Smoking Behaviors
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Cigarette Consumption
研究概览
简要总结
This within-subjects study aims to evaluate the effects of IQOS use on combustible cigarette smoking behaviors among 100 cigarette smokers who completed the study. After measuring baseline cigarette smoking rate, participants will receive an IQOS device and be instructed to use it (versus cigarettes) over a 14-day period. The investigators will also examine which objective and subjective effects of IQOS use predict a complete and incomplete switch from cigarettes to IQOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to communicate fluently in English (i.e. speaking, writing, and reading).
- •Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months.
- •Not currently undergoing smoking cessation treatment or planning to quit smoking within the next 30 days.
- •Report an interest in quitting smoking within the next 6 months.
- •Plan to live in the area for the duration of the study
- •Willing to use study provided IQOS devices and HeatSticks during 2 laboratory visits and throughout study participation.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
排除标准
- •Smoking Behavior
- •Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes for the duration of study will be considered eligible.
- •Current enrollment or plans to enroll in a smoking cessation program over the duration of the study (i.e. 21 days/3 weeks).
- •Provide a CO breath test reading less than 10 ppm at Intake.
- •Alcohol and Drug
- •History of substance abuse (other than nicotine dependence) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
- •Current alcohol consumption that exceeds 20 standard drinks/week.
- •Breath alcohol reading (BrAC) greater than .000 at Intake.
- •Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
- •Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
- •Psychiatric
- •Lifetime history of schizophrenia or psychosis.
- •Lifetime history or current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
- •Lifetime history of a suicide attempt.
- •General Exclusion
- •Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator.
- •Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
- •Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/o. Subjects may be deemed ineligible at any point throughout the study.
研究组 & 干预措施
IQOS
Other
干预措施: IQOS (Other)
结局指标
主要结局
Cigarette Consumption
时间窗: Day 1-Day 21 (21 days)
The primary outcome was the count of cigarettes per day (CPD) across the 14-day switch period (days 8-21) compared with the average CPD at baseline (days 1-5). This outcome was determined by counting each daily spent cigarette filter returned and self-reported CPD. The correlation between self-report and spent filter return was r=0.98. For the analysis, the daily counts were transformed to a percentage of the participant's average smoking rate from the baseline ad-lib smoking period.
次要结局
- Change in Motivation to Quit Smoking(Day 1-Day 21 (21 days))
研究者
Janet Audrain-McGovern
Professor
University of Pennsylvania
研究点 (2)
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