Impact of Switching to Non-Menthol Cigarettes Among Smokers

Tobacco Use Clinical Trial

Official title:

Impact of Switching to Non-Menthol Cigarettes Among Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075839
• Other study ID #: 2000020334
• Secondary ID: 1P50DA036151-01
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: February 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.

Description:

The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• 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 for a period of two weeks

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	Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes	Menthol smoking (Week 2), Non-menthol smoking (Week 4)
Secondary	Nicotine Dependence	Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence.	Week 4 (non-menthol)
Secondary	Quitting Interest	Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item "how important is quitting smoking to you?" from 1 "not at all" to 10 "extremely".	Week 4 (non-menthol)