NCT05703672

Switching to E-cigarettes in Smokers Not Interested in Quitting

4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Reduction

Interventions

Type	Name	Description
DRUG	Varenicline 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.
DRUG	Placebo	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.
OTHER	Electronic cigarette	Nicotine salt pod based e-cigarette in 5% nicotine

Timeline

• Start date: 2023-07-17
• Primary completion: 2026-12-07
• Completion: 2027-02-28
• First posted: 2023-01-30
• Last updated: 2025-12-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study