A Study on How Different E-Cigarette Flavors Affect Smoking Cessation in Adult Cigarette Smokers Using Electronic Nicotine Delivery Systems

What this Trial Is About

Researchers are investigating how the availability of different flavors in electronic nicotine delivery systems ENDS affects smoking abstinence among adult smokers of combustible cigarettes. This open-label, randomized controlled trial focuses on healthy adults aged 21 to 65 who currently use combustible cigarettes. The study aims to assess whether access to tobacco-flavored, menthol-flavored, mint, or other flavored e-liquids influences participants ability to stop smoking their usual cigarettes over a 13-week period. Participants will be randomly assigned to one of three groups with varying flavor options one group can choose tobacco and two non-tobacconon-mentholmint flavors, another can choose tobacco, mint, and menthol flavors, and the last group will have access only to tobacco flavor. All groups will use an ENDS device with a 5% nicotine level. The study starts with a one-week trial period for flavor sampling, followed by regular visits on Days 0, 30, 60, and 90. Some groups have optional visits in the first 4 weeks to try different flavors within their assigned options. Participants can use the ENDS and any other tobacco or nicotine products as they wish during the study. Participants will complete daily, weekly, and monthly surveys via a smartphone app, reporting cigarette use, flavor preferences, product satisfaction, quit attempts, and other factors influencing their smoking habits. The ENDS device will record usage patterns such as puff duration and intervals. Safety and adverse events will be monitored through a hotline throughout the study. The primary outcome is smoking abstinence during the final 7 days of the 13-week period. After study completion, participants return for a close-out visit and are discharged from the study.

A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers