RecruitingNot ApplicableNCT06260683

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

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


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

1,500 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria5

  • >= 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 Criteria12

  • 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

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Interventions

DRUGNicotine Replacement

Given nicotine patches and nicotine lozenges

OTHERQuestionnaire Administration

Ancillary studies

DEVICEVaping

Given Preferred Flavor e-liquid

DEVICEVaping

Given Tobacco flavored e-liquid


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06260683


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