Smoking Cessation in Menthol Flavored Cigarette Smokers

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Other: switch to non-menthol cigarettes prior to cessation attempt; Other: continue smoking menthol cigarettes prior to cessation attempt

• Registration Number: NCT02342327
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-28
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Results First Submitted: 2021-03-10
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Results First Posted: 2021-04-28
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Self identify as African American
• smoke primarily menthol cigarettes
• be between the ages of 18 and 64
• smoke a minimum number of cigarettes per day
• express an interest in quitting smoking

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Exclusion Criteria

• current unstable medical / psychiatric condition
• regular use any form of nicotine or tobacco other than cigarettes
• are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switch to non-menthol cigarettes	switch to non-menthol cigarettes prior to cessation attempt	Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking
Continue smoking menthol cigarettes	continue smoking menthol cigarettes prior to cessation attempt	Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking

Primary Outcome Measures

Name	Time	Method
Time to Lapse	6 months	Time from smoking cessation until first lapse (i.e. a cigarette is smoked)

Secondary Outcome Measures

Name	Time	Method
Time to Relapse	6 months	Days from the quit attempt until the first of seven consecutive smoking days

Trial Locations

Locations (1)

Clinical and Translational Sciences Institute; 🇺🇸 Minneapolis, Minnesota, United States