Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
研究概览
简要总结
The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.
详细描述
There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).
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
盲法说明
This study is a comparative randomized study.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoke ≥5 cigarettes per day for the past year
- •read, write, and speak in English
- •report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale)
- •participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.
排除标准
- •<21 years old
- •report NRT use or making a quit attempt within the last 7 days
- •current daily use of an e-cigarette over last month.
- •unstable or significant medical condition such as respiratory, kidney, or liver disease
- •unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- •history of cardiac event or distress within the past 6 months
- •currently pregnant, planning to become pregnant, or breastfeeding.
- •currently enrolled in a contradictory study.
- •cohabitates with a currently enrolled participant in the REACH study
- •reaction to using patch medication or adhesive tape
- •known allergy to propylene glycol or vegetable glycerin
结局指标
主要结局
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
时间窗: 12 weeks
Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes
时间窗: Daily for 12 weeks
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
次要结局
- Sociodemographic Questionnaire - Age(Baseline)
- Sociodemographic Questionnaire - Ethnicity(Baseline)
- Change in Motivation Rulers (Scale) From Baseline to Week 12(12 Weeks)
- Sociodemographic Questionnaire - Sex(Baseline)
- Sociodemographic Questionnaire - Employment Status(Baseline)
- Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)(12 Weeks)
- Minnesota Nicotine Withdrawal Scale(12 Weeks)
- Sociodemographic Questionnaire - Marital Status(Baseline)
- Sociodemographic Questionnaire - Socioeconomic Status(Baseline)
- Cigarette/EC Dependency Scale(12 weeks)
- Drug Effects/Liking Questionnaire(12 weeks)
- Cigarette Purchase Task - Breakpoint(Week 1 (Baseline))
研究者
Theodore Wagener
Principal Investigator
Ohio State University Comprehensive Cancer Center