Switching to E-cigarettes in Smokers Not Interested in Quitting
Start Date
7/17/2023
Completion Date
2/28/2027
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.
Detailed 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 exclusive EC, dual cig-EC, and exclusive cig users at week 6.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
Varenicline Tartrate
Placebo
Electronic cigarette
Conditions
Locations
Swope Health Central
Kansas City, Missouri 64130
United States
University of Kansas Medical Center
Kansas City, Missouri 64130
United States