Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT06264154

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

170 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to communicate fluently in English (speaking, writing, and reading)
  • Male and female smokers older than 21 years
  • Smoking at least 5 cigarettes per day for at least the last 12 months
  • At least 5 failed quit attempts and prior use of smoking cessation medication
  • 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 for 6 weeks using assigned flavors
  • Plan to live locally during the study
  • Able to give written informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Regular use of nicotine products other than cigarettes (more than 5 days in past 30 days)
  • Current or planned enrollment in a smoking cessation program during the study
  • Current use of smoking cessation medication
  • CO breath test less than 10 ppm at intake
  • History of substance abuse (except nicotine) in past 12 months
  • Current alcohol use exceeding 20 standard drinks per week
  • Current use of recreational drugs (except nicotine and cannabis)
  • Positive breath alcohol test at intake
  • Women who are pregnant, breastfeeding, or planning pregnancy during study
  • Serious or unstable disease in past year (e.g. cancer, heart disease)
  • Allergies to propylene glycol or flavor additives
  • Lifetime history of schizophrenia or psychosis
  • Enrollment in conflicting research programs
  • Any medical or psychiatric condition that risks participant safety or study integrity
  • Significant non-compliance with study protocol as determined by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

J

Janet Audrain-McGovern, Ph.D.

CONTACT

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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