4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) .
研究概览
简要总结
The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in adult (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking.
详细描述
Adult cigarette smokers (n=500) who are interested in switching to a nicotine salt-based electronic cigarette (EC) and are not established EC users will receive a 6-week supply of the EC and assistance with switching. After six weeks, those that are dual users (n=221) will receive an additional 12 weeks of the EC and be randomized in a 2:1 fashion to receive 12 weeks of varenicline (VAR) or placebo (PBO) and additional counseling to support a complete switch. Follow-up for all participants will continue through week 52. The primary outcome is change in the potent lung carcinogen, NNAL, between exclusive EC, dual cig-EC, and exclusive cig users at week 6.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 21 years of age
- •Smoke >5 cigarettes per day
- •Smoked cigarettes for > 6 months
- •Verified smoker (CO > 5 ppm)
- •Functioning telephone
- •Interested in switching to EC
- •Willing to take varenicline and complete all study visits
排除标准
- •Interested in quitting smoking
- •Use of smoking cessation pharmacotherapy in the month prior to enrollment
- •Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)
- •EC use on > 4 of the past 30 days
- •Uncontrolled hypertension: BP > 180 (systolic) or > 105 (diastolic)
- •Heart-related event in the past 30 days
- •Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation
- •Pregnant, contemplating getting pregnant, or breastfeeding
- •Plans to move from Kansas City metro area during the treatment and follow-up phase
- •Another household member enrolled in the study
研究组 & 干预措施
Varenicline and electronic cigarette
At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
干预措施: Varenicline Tartrate (Drug)
Varenicline and electronic cigarette
At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
干预措施: Electronic cigarette (Other)
Placebo and electronic cigarette
At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
干预措施: Placebo (Drug)
Placebo and electronic cigarette
At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
干预措施: Electronic cigarette (Other)
Open label electronic cigarette
All participants will receive an initial 6-week supply of the study electronic cigarette.
干预措施: Electronic cigarette (Other)
结局指标
主要结局
Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) .
时间窗: Week 6
Reduction in toxicant exposure as measured by NNAL excretion from baseline to week 6.
次要结局
- Carbon Monoxide (CO) verified 7-day point prevalence abstinence from cigarettes(Week 12 post randomization)