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RECRUITING Phase 3 ClinicalTrials.gov

Switching to E-cigarettes in Smokers Not Interested in Quitting

Sponsor: University of Kansas Medical Center • ClinicalTrials.gov ID: NCT05703672

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Varenicline Tartrate (Drug)
    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.
  • Placebo (Drug)
    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.
  • Electronic cigarette (Other)
    Nicotine salt pod based e-cigarette in 5% nicotine

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 getting pregnant, or breastfeeding * Plans to move from Kansas City metro area during the treatment and follow-up phase * Another household member enrolled in the study

Conditions

Smoking Reduction

Locations

  • Swope Health Central — Kansas City, Missouri, United States
  • University of Kansas Medical Center — Kansas City, Missouri, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record