4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users
University of Kansas Medical Center
Summary
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.
Description
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…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * ≥ 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 Exclusion Criteria: * 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 (diasto…
Interventions
- DrugVarenicline Tartrate
0.5 mg once daily for days 1-3, 0.5mg twice daily for days 4-7 and 1.0 mg twice daily from day 8 through week 12.
- DrugPlacebo
One pill (white) once daily for days 1-3, one pill (white) twice daily for days 4-7 and one pill (blue) twice daily from day 8 through week 12.
- OtherElectronic cigarette
Nicotine salt pod based e-cigarette in 5% nicotine
Locations (2)
- Swope Health CentralKansas City, Missouri
- University of Kansas Medical CenterKansas City, Missouri