Switching to E-cigarettes in African-American Smokers

• Status: Not yet recruiting
• Trial end date: 2025-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• African American

• ≥ 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