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Switching to E-cigarettes in Smokers Not Interested in Quitting

RecruitingPhase 3Ages 21 Years - anyAllUniversity of Kansas Medical Center
NCT05703672 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Varenicline Tartrate
  • Placebo
  • Electronic cigarette
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Where

2 sites
Swope Health Central
Kansas City, United States
University of Kansas Medical Center
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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