A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers

Description

This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end-of-study abstinence of healthy adult consumers of combustible cigarettes when provided an electronic nicotine delivery system over a three-month (ninety-day) ambulatory study period.

Potential participants will be recruited and enrolled at 27 sites across the United States. Ipsos will recruit participants in person (e.g., through mall intercepts) at each site or by telephone from existing databases of previous research participants. Based on meeting eligibility requirements, participants will be required to read and sign an Informed Consent Form and to attend a site visit to complete enrollment.

At the Enrollment Visit, participants will be randomized to one of the three study arms. All participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their assigned study arm.

All participants will attend mandatory follow-up site visits on Day 0, Day 30, Day 60, and Day 90, with the option of changing to a different flavor among the available flavors based upon their assigned study arm, if applicable. In the first four weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits on Day 7, Day 14, and Day 21, with the option of changing flavors among those available in their assigned study arm. All site visits will record the number of study investigational product cartridges dispensed, in addition to all used and unused investigational product cartridges returned.

During the three-month ambulatory study period, participants will be free to use the study investigational product and any other tobacco or nicotine products as desired. The electronic nicotine delivery system (Version 2) power unit technology will measure their puffing topography during use (including puff duration and the time interval between puffs). The puffing topography data will be automatically transferred to a secure online database via a Bluetooth transfer application using the provided smartphone.

Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on the provided smartphone. Surveys will collect data on:

1. The number of cigarettes smoked the previous day
2. Current flavor use
3. Product liking
4. Number of cigarette quit attempts
5. Use of other tobacco or nicotine products
6. Intent to substitute their usual brand combustible cigarettes for the study investigational product (e.g., gradual, complete, or future intent)
7. Social and environmental factors influencing switching intent

At the conclusion of the ambulatory study period, all participants will return to the study sites for a close-out period and will then be discharged from the study.