A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
Ohio State University Comprehensive Cancer Center
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.
Description
PRIMARY OBJECTIVES: I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked. II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence. III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks. OUTLINE: Participants are randomized to 1 of 3 arms. ARM I: Participants receive PEC for 14 weeks, includin…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
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 distres…
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
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio