Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- carbon monoxide (CO)
研究概览
简要总结
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
详细描述
The purpose of this study is to provide preliminary information on the effect of electronic cigarettes (EC) and nicotine replacement therapy (NRT) among SWO. This study will randomize up to 60 individuals who smoke cigarettes with comorbid obesity (SWO) to receive (1) electronic cigarettes (EC), (2) nicotine replacement therapy (NRT), or 3) a no-product control (CON) condition for 8 weeks. Assessments will occur at baseline, and 1, 2, and 3-months follow-up, aiming: 1) To compare EC, NRT, and CON on smoking, exhaled carbon monoxide, and number of quit attempts; 2) To compare EC and NRT on acceptability and adherence; 3) To compare EC, NRT, and CON effects on weight, central adiposity, glucose regulation, inflammation, cotinine, and blood pressure at follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will not know the outcome of randomized assignment.
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
- •body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)
- •smoked ≥ 5 cigarettes/day during the past year
- •21 or older (due to minimum legal age EC restrictions)
- •exhaled breath carbon monoxide (CO) level > 6 ppm at Baseline (BL) (to confirm self-reported smoking)
- •willing to use EC or NRT for 8 weeks
- •access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)
排除标准
- •received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),
- •currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)
- •hospitalized for mental illness in past 30 days
- •heart-related event (e.g., heart attack, severe angina) in past 30 days
- •residing with another person currently enrolled in the study
- •pregnant, nursing, or planning to become pregnant in the next 6 months
- •medical contraindication for study or product use (e.g., allergy to adhesives)
- •taken prescription weight loss medication in the last 30 days
研究组 & 干预措施
No-Product Control Condition (CON)
Participants in this condition will not receive any alternate nicotine product.
Electronic Cigarette (EC) Condition
Participants in this condition will receive the EC intervention.
干预措施: Electronic Cigarettes (EC) (Other)
Nicotine Replacement Therapy Condition
Participants in this condition will receive the NRT intervention.
干预措施: Nicotine replacement therapy (NRT) (Other)
结局指标
主要结局
carbon monoxide (CO)
时间窗: 2 months
Exhaled breath sample used to measure carbon monoxide
number of cigarettes per day
时间窗: 2 months
Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.
number of quit attempts
时间窗: 2 months
Number of attempts to quit smoking during the experimental period
次要结局
- product acceptability(2 months)
- product adherence(2 months)
- change in weight(2 months)
- change in waist circumference(2 months)
- A1c(2 months)
- interleukin-6 (IL-6)(2 months)
- cotinine(2 months)
- diastolic blood pressure(2 months)
- systolic blood pressure(2 months)