Study on How E-cigarette Flavors Affect Switching From Cigarettes in Persistent Smokers
Randomized Trial Comparing Fruit, Tobacco, and Menthol Flavors Over Six Weeks
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-02-19
210
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how the flavor of e-cigarettes affects the ability of persistent cigarette smokers to switch from traditional combustible cigarettes to e-cigarettes. The study focuses on whether fruit-flavored e-cigarettes are more appealing and easier to switch to compared to tobacco or menthol flavors. This research addresses the public health challenge of helping smokers who struggle to quit by exploring flavors role in encouraging substitution with less harmful products.
The study will randomly assign 210 cigarette smokers to use one of three flavor types of e-cigarettesfruit-flavored watermelon and blueberry, tobacco-flavored, or menthol-flavoredfor six weeks. Participants receive an e-cigarette device and nicotine pods in their assigned flavor, with supplies given weekly based on their baseline smoking habits. Before switching, their smoking rates are measured, and after a verified overnight abstinence, their responses to flavors and the value of flavored e-cigarettes compared to cigarettes are assessed in the laboratory.
During the study, participants are instructed to switch fully to using the assigned e-cigarette flavor instead of cigarettes for six weeks. They will collect daily cigarette filter samples to track cigarette use. The main measure is the daily cigarette count from baseline through the six-week period, with a follow-up at six months to assess longer-term cigarette consumption. The research team will monitor participants throughout to understand how flavor influences switching behavior and its potential as a harm reduction strategy.
CONDITIONS
Brief Title
The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers
Research Team
J
Janet Audrain-McGovern, Ph.D.
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Fruit-flavored E-cigarettes
Tobacco-flavored E-cigarettes
Menthol-flavored E-cigarettes
What is it?
Participants use an e-cigarette device with fruit-flavored nicotine pods as a substitute for their usual cigarettes.
Participants use an e-cigarette device with tobacco-flavored nicotine pods instead of combustible cigarettes.
Participants use an e-cigarette device with menthol-flavored nicotine pods to replace conventional cigarettes.
Role in the trial
Intervention arm testing whether fruit-flavored e-cigarettes can substitute for combustible cigarettes among persistent adult smokers.
Comparator arm evaluating tobacco-flavored e-cigarettes for combustible cigarette reduction or substitution.
Comparator arm evaluating menthol-flavored e-cigarettes for their ability to substitute for cigarettes.
Primary use or goal
To assess if fruit-flavored e-cigarettes help persistent adult smokers switch away from combustible cigarettes.
To assess if tobacco-flavored e-cigarettes support switching away from combustible cigarettes among persistent smokers.
To test whether menthol-flavored e-cigarettes can facilitate substitution for combustible cigarettes for the same population.
How it is given or performed
Participants are provided with an e-cigarette device and assigned fruit-flavored nicotine pods. They are instructed to switch completely from conventional cigarettes to e-cigarette use for 6 weeks.
Participants receive an e-cigarette device with tobacco-flavored pods and are instructed to substitute e-cigarettes for smoking for 6 weeks.
Participants receive an e-cigarette device with menthol-flavored nicotine pods, using e-cigarettes instead of smoking for the study period.
What is known from published research?
Clinical research is ongoing. Existing studies suggest fruit-flavored e-cigarettes may be more appealing to some adult smokers, which could influence switching success, but direct substitution and reduction of combustible smoking require confirmation in ongoing trials.
Tobacco-flavored e-cigarettes are standard reference in most clinical studies, with mixed evidence about their acceptability and effectiveness for combustible cigarette substitution among adults; evidence of superiority over fruit or menthol flavors is not established.
Menthol-flavored e-cigarettes are often preferred by menthol cigarette users, but clinical effectiveness for overall cigarette reduction/substitution, especially compared to fruit or tobacco flavors, is under current investigation.
Important limitations or study gaps
Effectiveness for long-term cigarette cessation is not yet established. Regulatory policy around flavors may change and affect real-world availability. Study is limited to persistent adult smokers with failed prior quit attempts, which may reduce applicability to broader populations.
Uncertainty remains about whether tobacco-flavored e-cigarettes are effective for persistent smokers, especially those previously unsuccessful with quit attempts. Variation in flavor acceptability may influence results.
Preference data support menthol use, but lack of conclusive outcome results for combustible cigarette substitution. Results may not apply to all smoker populations. Regulatory changes may restrict product availability in the future.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 21Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Able to communicate fluently in English (speaking, writing, and reading)
Male or female smokers aged 21 years or older
Self-report smoking at least 5 cigarettes per day for the past 12 months or longer
Have 5 or more failed quit attempts and used smoking cessation medication at least once
Have ever used an e-cigarette
Carbon monoxide (CO) level greater than 10 ppm
Not regularly using nicotine products other than cigarettes
Willing to switch to e-cigarettes and use assigned flavors for 6 weeks
Plan to live in the study area during the study period
Able to give written informed consent and comply with study requirements
You will not qualify if you...
Regular use of nicotine products other than cigarettes more than 5 days in the past 30 days
Current enrollment or planned enrollment in a smoking cessation program during the study
Current use of smoking cessation medication
Carbon monoxide breath test reading less than 10 ppm at intake
History of substance abuse (except nicotine dependence) in past 12 months
Current alcohol use exceeding 20 standard drinks per week
Current use of recreational drugs other than nicotine and cannabis
Positive breath alcohol test at intake
Pregnant, breastfeeding, or planning pregnancy during the study period
Serious or unstable disease within the past year (e.g., cancer, heart disease)
Allergies to propylene glycol or flavor additives
Lifetime history of schizophrenia or psychosis
Participation in other research programs that may affect safety or study data
Any medical condition or medication affecting safety or study performance as judged by the Principal Investigator
Significant non-compliance with study protocol or design as determined by the Principal Investigator
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline and Laboratory Assessments
Duration - 7 days
Participants establish baseline smoking rates and complete laboratory visits to assess flavor-associated subjective reward and reinforcing value of flavored e-cigarettes relative to combustible cigarettes.
Daily visits from Day 1 to Day 7 including 2 laboratory visits on Days 6 and 7
Treatment
Duration - 6 weeks
Participants switch from smoking combustible cigarettes to using assigned fruit-, tobacco-, or menthol-flavored e-cigarettes for six weeks.
Weekly visits for supply of nicotine pods and assessments over 6 weeks
Follow-up
Duration - Approximately 4.5 months
Participants are followed for smoking behavior and cigarette consumption up to six months after the treatment period.
1 follow-up visit at 6 months post-treatment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Evaluating the substitutability of fruit versus menthol and tobacco-flavored e-cigarettes on combustible cigarette cessation: Randomized clinical trial protocol.
Olivia Klapec, Andrew A Strasser, E Paul Wileyto...