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Recruiting Phase 3 NCT05703672

Switching to E-cigarettes in Smokers Not Interested in Quitting

Trial Parameters

Condition Smoking Reduction
Sponsor University of Kansas Medical Center
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 500
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2023-07-17
Completion 2026-12-07
Interventions
Varenicline TartratePlaceboElectronic cigarette

Brief 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.

Eligibility Criteria

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 (diastolic) * Heart-related event in the past 30 days * Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation * Pregnant, contemplating

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