Switching to E-cigarettes in Smokers Not Interested in Quitting

Adult cigarette smokers (n=500) who are interested in switching to a nicotine salt-based electronic cigarette (EC) and are not established EC users will receive a 6-week supply of the EC and assistance with switching. After six weeks, those that are dual users (n=221) will receive an additional 12 weeks of the EC and be randomized in a 2:1 fashion to receive 12 weeks of varenicline (VAR) or placebo (PBO) and additional counseling to support a complete switch. Follow-up for all participants will continue through week 52. The primary outcome is change in the potent lung carcinogen, NNAL, between exclusive EC, dual cig-EC, and exclusive cig users at week 6.

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