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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04009850
• Other study ID #: 2000025572
• Secondary ID: 2U54DA036151-06
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 31, 2022
• Est. primary completion date: November 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 or older

• Able to read English

• Cigarette smoker

Exclusion Criteria:

• Seeking smoking cessation treatment

• Serious psychiatric or medical condition

• Use of other drugs

• Unable or unwilling to complete study protocol

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Cigarette Brand Switching
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
• E-cigarette Flavor
Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Cigarettes Smoked	Self-reported total number of cigarettes smoked per day (Timeline Follow Back)	Week 6
Secondary	E-cigarette Use	Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)	Week 6
Secondary	Tobacco Product Satisfaction	Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction	Week 6
Secondary	Motivation to Quit Smoking	Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit	Week 6
Secondary	Nicotine Dependence	Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence	Week 6