Switching to E-cigarettes in African-American Smokers

Status Recruiting

Clinical Trial 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 African American (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.

Clinical Trial Description

African American (AA) 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. ;

Study Design

Related Conditions & MeSH terms

Smoking Reduction

Clinical Trial Details

NCT number	NCT05703672
Study type	Interventional
Source	University of Kansas Medical Center
Contact	Tricia Snow, MPH
Phone	816-398-8960
Email	psnow@kumc.edu
Status	Recruiting
Phase	Phase 3
Start date	July 17, 2023
Completion date	February 1, 2026

View Details

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