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

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.

Study Overview

• Status: Terminated
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Cigarette Brand Switching; Other: E-cigarette Flavor

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menthol e-cigarette; Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette	Other: Cigarette Brand Switching; Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Experimental: Tobacco e-cigarette; Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette	Other: E-cigarette Flavor; Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Cigarettes Smoked	Self-reported total number of cigarettes smoked per day (Timeline Follow Back)	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-cigarette Use	Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)	Week 6
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
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
Nicotine Dependence	Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence	Week 6

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Krysten Bold, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): November 9, 2019
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2000025572; 2U54DA036151-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No