Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

Not Applicable

Terminated

• Conditions: Tobacco Use
• Interventions: Other: Cigarette Brand Switching; Other: E-cigarette Flavor

• Registration Number: NCT04009850
• Lead Sponsor: Yale University

Brief Summary

This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

Detailed Description

The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Primary Completion: 2019-11-09
• Study Completion: 2022-01-31
• Results First Submitted: 2022-02-10
• Results First Submitted QC: 2022-04-25
• Results First Posted: 2022-05-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• 18 or older
• Able to read English
• Cigarette smoker

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Exclusion Criteria

• Seeking smoking cessation treatment
• Serious psychiatric or medical condition
• Use of other drugs
• Unable or unwilling to complete study protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menthol e-cigarette	Cigarette Brand Switching	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Tobacco e-cigarette	E-cigarette Flavor	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette

Primary Outcome Measures

Name	Time	Method
Total Number of Cigarettes Smoked	Week 6	Self-reported total number of cigarettes smoked per day (Timeline Follow Back)

Secondary Outcome Measures

Name	Time	Method
Motivation to Quit Smoking	Week 6	Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit
E-cigarette Use	Week 6	Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)
Nicotine Dependence	Week 6	Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence
Tobacco Product Satisfaction	Week 6	Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States