NCT06260683

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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, including a 2-week pre-switch period to become familiar with usage. ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. ARM III: 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. SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

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

Timeline

• Start date: 2024-04-10
• Primary completion: 2028-04-12
• Completion: 2028-04-12
• First posted: 2024-02-15
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study