NCT06264154

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

August 26, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

February 8, 2024

Last Update Submit

February 17, 2026

Conditions

SmokingTobacco UseCigarette SmokingE-Cig Use

Outcome Measures

Primary Outcomes (2)

  • 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).

    42 days (days 8 - 49)

  • Cigarette Smoking Behavior

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

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

Study Arms (3)

Fruit-flavored E-cigarettes

EXPERIMENTAL

Participants randomized to fruit-flavored e-cigarettes will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study provided e-cigarette device and fruit-flavored nicotine pods. Participants will be able to choose between blueberry or watermelon-flavored pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior.

Other: E-cigarettes

Tobacco-flavored E-cigarettes

ACTIVE COMPARATOR

Participants randomized to tobacco-flavored e-cigarettes will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study provided e-cigarette device and tobacco nicotine pods. Participants will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior.

Other: E-cigarettes

Menthol-flavored E-cigarettes

ACTIVE COMPARATOR

Participants randomized to menthol-flavored e-cigarettes will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study provided e-cigarette device and menthol nicotine pods. Participants will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior.

Other: E-cigarettes

Interventions

E-cigarettesOTHER

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.

Fruit-flavored E-cigarettesMenthol-flavored E-cigarettesTobacco-flavored E-cigarettes

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
  • Ever use of an e-cigarette
  • Have a carbon monoxide (CO) greater than 10 ppm
  • Not using any forms of nicotine regularly other than cigarettes
  • Be willing to switch to e-cigarettes for 6 weeks and use the assigned flavors
  • Plan to live in the area for the duration of the study
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

You may not qualify if:

  • Smoking Behavior Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette use is defined as greater than 5 days/past 30 days
  • 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.
  • Alcohol and Drug
  • History of substance abuse (other than nicotine dependence) in the past 12 months.
  • Current alcohol consumption that exceeds 20 standard drinks/week.
  • Current use of recreational drugs (other than nicotine and cannabis)
  • Breath alcohol reading (BrAC) greater than .000 at Intake.
  • Medical
  • Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
  • Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
  • Allergies to either propylene glycol or flavor additives
  • Psychiatric
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

SmokingTobacco UseCigarette SmokingVaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

BehaviorTobacco Smoking

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Janet Audrain-McGovern, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Audrain-McGovern, Ph.D.

CONTACT

(215) 746-7145audrain@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

August 26, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)