About this trial
This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes will be assessed as mechanisms.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to communicate fluently in English (i.e. speaking, writing, and reading)
Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months
5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
Ever use of an e-cigarette
Disqualifiers
Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible.
Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
Current use of smoking cessation medication
Provide a CO breath test reading less than 10 ppm at Intake.
Trial design
Single group
Treatments tested in this trial
E-cigarettes
Other interventionAll participants are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. Participants will receive an e-cigarette device and flavored nicotine pods according to their randomly assigned flavor.
Treatment groups
Trial outcomes
Primary outcomes
Cigarette Consumption
The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the e-cigarette switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49).
Cigarette Smoking Behavior
Cigarette smoking behavior at the 6-month follow-up will serve as a secondary endpoint.
Sponsors and contacts
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Abramson Cancer Center at Penn Medicine
Lead sponsor
University of Pennsylvania
Sponsor institution
National Cancer Institute (NCI)
Collaborator
University of Pennsylvania
Collaborator