The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAbramson Cancer Center at Penn Medicine

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • E-cigarettes

    Other intervention

    All 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

210 Participants
are divided into 3 treatment groups
Group A: Fruit-flavored E-cigarettesExperimental treatment 1 intervention
Group B: Tobacco-flavored E-cigarettesActive comparator 1 intervention
Group C: Menthol-flavored E-cigarettesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
42 days (days 8 - 49)
2

Cigarette Smoking Behavior

Cigarette smoking behavior at the 6-month follow-up will serve as a secondary endpoint.

Time frame
19 Weeks (Day 50-6-Month Follow-Up)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

University of Pennsylvania

Sponsor institution

National Cancer Institute (NCI)

Collaborator

University of Pennsylvania

Collaborator