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

NCT ID: NCT04009850

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-01-31

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Menthol e-cigarette

Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette

Group Type: EXPERIMENTAL

Cigarette Brand Switching

Intervention Type: OTHER

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes

Tobacco e-cigarette

Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette

Group Type: EXPERIMENTAL

E-cigarette Flavor

Intervention Type: OTHER

Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes

Interventions

Cigarette Brand Switching

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes

Intervention Type: OTHER

E-cigarette Flavor

Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krysten Bold, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2U54DA036151-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000025572

Identifier Type: -

Identifier Source: org_study_id