Study of Aggressive Smoking Cessation Therapy Using Varenicline and Nicotine E-Cigarettes in Adults at High Cardiovascular Risk

What this Trial Is About

Researchers are evaluating aggressive smoking cessation therapy for adults at elevated cardiovascular risk who currently smoke at least 10 cigarettes daily and are motivated to quit. This 5-year, multi-center randomized controlled trial compares a combination of varenicline and nicotine e-cigarettes plus counseling to varenicline plus counseling alone. The study aims to determine which treatment better helps people stop smoking and reduces cigarette consumption, while assessing safety and side effects. Participants will be randomly assigned to one of two groups one receiving varenicline alongside nicotine e-cigarettes and counseling, and the other receiving varenicline with counseling only for 12 weeks. Varenicline dosing starts low and increases to 1 mg twice daily, with adjustments if side effects occur. Those in the combination group receive funds to buy e-cigarettes and nicotine cartridges, with monitoring of use and receipts. Follow-up includes telephone calls and clinic visits up to 52 weeks. During the study, participants will report smoking habits, treatment adherence, and any adverse effects. Smoking cessation is confirmed with breath tests measuring carbon monoxide levels. Researchers will track smoking abstinence, reduction in cigarettes smoked, and safety outcomes. Clinic visits occur at weeks 4, 12, 24, and 52, with telephone follow-ups at weeks 1, 2, 8, and 18. The primary measure is smoking abstinence at 24 weeks, with continued monitoring through one year.

Aggressive Smoking Cessation Trial (ASAP)