The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Daily Cigarette Consumption
研究概览
简要总结
The purpose of this study is to examine the effect of changes in cigarette package color on smoking behaviors, harm exposure, and risk perceptions when using low nicotine content (LNC) cigarettes.
详细描述
This project will utilize a randomized, parallel-design trial to examine the effects of low nicotine content (LNC) cigarette packaging on smoking behaviors, harm exposure, risk perceptions, and subjective ratings of cigarettes. The investigators will aim to recruit and randomize 500 daily smokers (~250 male, ~250 female) in a 35-day protocol. After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control), or LNC cigarettes in one of four types of packaging: standard investigational (gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy). Participants will be asked to attend 5 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 5, 10, 20 & 35. At Intake and Days 15, 25 and 30 participants will complete sessions with research staff remotely (i.e. by video call). Sessions will occur every 4-6 days, for a total of 5 in-person and 4 remote sessions across 35 days.
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
- Single (Participant)
盲法说明
Participants will be informed that they will be supplied with study cigarettes with a low nicotine content, but will be blinded to the exact nicotine content and unaware that all packages will contain the same type of low nicotine content cigarette.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months.
- •Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (~5 weeks).
- •Plan to live in the area for the duration of the study.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- •Able to communicate fluently in English (i.e., speaking, writing, and reading).
排除标准
- •Smoke menthol cigarettes greater than 20% of the time.
- •Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.)
- •Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
- •Attempt to quit smoking over the duration of the study period.
- •Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0).
- •History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol.
- •Current alcohol consumption that exceeds 25 standard drinks/week.
- •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.
- •Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- •Color blindness.
- •Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- •Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
- •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.
- •Additional, general reasons for exclusion include:
- •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 and/or Study Physician.
- •Any circumstance, 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 and/or Study Physician. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.
- •Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn at any point throughout the study.
研究组 & 干预措施
Own Brand
After completing a 5-day baseline period of smoking their own brand, participants will complete a 30-day experimental period when they will continue to receive their own preferred brand of cigarettes (i.e., control group).
干预措施: Own Brand (Other)
LNC Cigarettes + Gray Packaging
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in standard investigational packaging (gray).
干预措施: LNC Cigarettes + Colored Packaging (Other)
LNC Cigarettes + Red Packaging
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in red packaging.
干预措施: LNC Cigarettes + Colored Packaging (Other)
LNC Cigarettes + Blue Packaging
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in blue packaging.
干预措施: LNC Cigarettes + Colored Packaging (Other)
LNC Cigarettes + Plain Packaging
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in plain packaging.
干预措施: LNC Cigarettes + Colored Packaging (Other)
结局指标
主要结局
Daily Cigarette Consumption
时间窗: Day 0 through Day 35
Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters for all cigarettes smoked throughout the entire 35-day study.
Total Nicotine Equivalents
时间窗: Days 5 and 35
Urine collected at Day 5 and Day 35 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-35). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).
Total Puff Volume/Puff Duration
时间窗: Day 0 through Day 35
Total puff volume/puff duration (the sum of all puff volumes/duration per cigarette) will be collected for each cigarette smoked during each laboratory session using a standardized video scoring procedure. Total puff volume will be assessed for each cigarette smoked at in-person and remote sessions throughout the entire 35-day study.
Carbon Monoxide (CO)
时间窗: Days 0, 5, 10, 20 and 35
The investigators will assess CO (measured in parts per million \[ppm\]), a measure of toxicant exposure, at the onset of each session, as well as before and after each cigarette smoked during each in-person laboratory session. CO collected at the onset of each session represents daily exposure, while CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette.
Total NNAL
时间窗: Days 5 and 35
Urine collected at D5 and D35 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-35). Total NNAL will be measured in nanograms per milliliter (ng per mL).
次要结局
- Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)(Days 0, 5, 10, 20 and 35)
- Cigarette Craving (Questionnaire on Smoking Urges [QSU])(Days 0, 5, 10, 20 and 35)
- Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])(: Days 0, 5, 10, 20 and 35)
- Cigarette Risk Beliefs(Days 0, 5, 20, and 35)
- Total Puff Count(Day 0 through Day 35)
- Puff Duration(Day 0 through Day 35)