Study 2: Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Nicotine Beliefs
研究概览
简要总结
The purpose of this study is to examine the effect of nicotine messaging and nicotine content of study cigarettes on nicotine beliefs and subsequent use of tobacco and nicotine products.
详细描述
This project will utilize a randomized, factorial design trial to examine the effects of nicotine messaging on nicotine harm beliefs and smoking behavior. After a 7-day period of smoking own preferred brand cigarettes, participants will begin a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes. The investigators will aim to recruit and randomize 160 current, daily cigarette smokers (80 male, 80 female) in a 35-day protocol. Participants will be asked to attend 6 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 7, 14, 21, 28 & 35. Sessions will occur every 6-8 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants are unblinded to the nicotine content of their cigarette, either normal nicotine content (NNC) cigarettes or reduced nicotine content (RNC) cigarettes. However, participants will not be aware of the messaging condition assignment, either Nicotine Corrective Messaging (NCM) or the Delayed Control Messaging.
入排标准
- 年龄范围
- 21 Years 至 —（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 (~6 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.
结局指标
主要结局
Nicotine Beliefs
时间窗: Day 35
Nicotine belief measures will be assessed by participant self-report and comprised of four broad constructs (nicotine beliefs, NRT beliefs, e-cigarette beliefs, and RNC cigarette beliefs). Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Three items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarettes false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.
次要结局
- Daily Cigarette Consumption(Day 35)
- Puff Duration(Day 35)
- Carbon Monoxide (CO)(Day 35)
- Number of Participants With Intention to Use Tobacco/Nicotine Products(Day 35)
- Tobacco Use(Day 35)
- Subjective Cigarette Ratings(Day 35)
研究者
Andrew Strasser
Associate Professor
Abramson Cancer Center at Penn Medicine