A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06260683
Status
Recruiting
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Conditions

  • Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nicotine Replacement — DRUG
    Given nicotine patches and nicotine lozenges
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Vaping — DEVICE
    Given Preferred Flavor e-liquid
  • Vaping — DEVICE
    Given Tobacco flavored e-liquid

Study Details

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.

Key Dates

Start date
Apr 10, 2024
Status verified
Mar 2026
Primary completion
Apr 12, 2028
Completion
Apr 12, 2028

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (PEC)
    Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
  • Experimental: Arm II (TEC)
    Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
  • Active Comparator: Arm III (NRT)
    Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.

Primary Outcome Measure

7-day point prevalence complete switching rate [ Time Frame: At week 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Theodore L. Wagener, PhD
[email protected]
Theodore L. Wagener, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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