Actively Recruiting
The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-02-19
210
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
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 flavor's 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-cigarettes—fruit-flavored (watermelon and blueberry), tobacco-flavored, or menthol-flavored—for 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
Who Can Participate
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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
J
Janet Audrain-McGovern, Ph.D.
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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