Recruiting

Tobacco ECs, Non-Tobacco ECs, NRT

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06260683

Conditions

Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Nicotine Replacement

Questionnaire Administration

Vaping

Vaping

Study Details

Brief summary:

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.

Conditions

Cigarette Smoking-Related Carcinoma

Study ID

NCT06260683

Start date

Apr 10, 2024

Status verified date

Mar, 2026

Completion date

Apr 12, 2028

Anticipated

Primary completion date

Apr 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • >= 21 years old
  • Smoke >= 5 cigarettes per day for the past year
  • Willing to use either an EC or NRT
  • Read and speak English
  • Have a smartphone

Exclusion Criteria:

  • Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
  • Current use of an EC > 4 days a month
  • Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
  • Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
  • History of cardiac event or distress within the past 3 months
  • Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
  • High blood pressure not controlled by medications
  • Serious angina pectoris or chest pain
  • Stroke within the past three months
  • Known allergy to propylene glycol or vegetable glycerin
  • Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
  • Live in same household as another study participant

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Nicotine Replacement

Given nicotine patches and nicotine lozenges

Questionnaire Administration

Ancillary studies

Vaping

Given Preferred Flavor e-liquid

Vaping

Given Tobacco flavored e-liquid

Primary outcome measure

  • 7-day point prevalence complete switching rate [ Time Frame: At week 14 ]
  • Biochemically verified 7-day point prevalence abstinence from cigarettes [ Time Frame: At week 14 ]
  • Cigarettes smoked per day [ Time Frame: At week 14 ]

Central Contacts and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Theodore L. Wagener, PhD

Theodore.Wagener@osumc.edu

Principal Investigator:

Theodore L. Wagener, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-04-06.