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NCT05703672
Switching to E-cigarettes in African-American Smokers
Conditions: Smoking Reduction
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 500
Sponsor: University of Kansas Medical Center
Location: United States
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 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.
Eligibility Criteria
Inclusion Criteria:African American≥ 21 years of ageSmoke >5 cigarettes per daySmoked cigarettes for > 6 monthsVerified smoker (CO > 5 ppm)Functioning telephoneInterested in switching to ECWilling to take varenicline and complete all study visitsExclusion Criteria:Interested in quitting smokingUse of smoking cessation pharmacotherapy in the month prior to enrollmentUse of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)EC use on > 4 of the past 30 daysUncontrolled hypertension: BP > 180 (systolic) or > 105 (diastolic)Heart-related event in the past 30 daysMedical 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 ideationPregnant, contemplating getting pregnant, or breastfeedingPlans to move from Kansas City metro area during the treatment and follow-up phaseAnother household member enrolled in the study
Source: ClinicalTrials.gov (NCT05703672). StuddyBuddy aggregates publicly available trial information.