University of Kansas Medical Center
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.
Smoking Reduction
Varenicline Tartrate
Placebo
Electronic cigarette
Phase 3
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 Type : | Interventional |
| Estimated Enrollment : | 500 participants |
| Masking : | Quadruple |
| Primary Purpose : | Prevention |
| Official Title : | 4th Generation E-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users |
| Actual Study Start Date : | July 17, 2023 |
| Estimated Primary Completion Date : | August 30, 2025 |
| Estimated Study Completion Date : | February 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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. |
Drug: Varenicline Tartrate |
|
Placebo Comparator: 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. |
Other: Electronic cigarette |
|
Other: Open label electronic cigarette All participants will receive an initial 6-week supply of the study electronic cigarette. |
Drug: Placebo |
| Ages Eligible for Study: | 21 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Swope Health Central
Kansas City, missouri, United States, 64130
Recruiting
University of Kansas Medical Center
Kansas City, missouri, United States, 64130