Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Other: No menthol ban; Other: Menthol ban on cigarettes and e-cigarettes; Other: Menthol ban on cigarettes

• Registration Number: NCT03402243
• Lead Sponsor: University of Minnesota

Brief Summary

In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-18
• Study Start: 2018-02-26
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Results First Submitted: 2021-06-25
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Results First Posted: 2021-08-10
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Be between the ages of 18 and 64
• Purchase exclusively menthol cigarettes
• Not currently motivated to quit smoking
• Smoking a minimum number of cigarettes per day

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Exclusion Criteria

• Report a serious, unstable medical or psychiatric condition
• Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
• Have used any smoking cessation therapy during the past month
• Regularly use any form of tobacco other than cigarettes
• Are pregnant or breast feeding or planning to become pregnant or breast feed during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Menthol Ban	No menthol ban	Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban for cigarettes and e-cigarettes	Menthol ban on cigarettes and e-cigarettes	Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban only for cigarettes	Menthol ban on cigarettes	Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge

Primary Outcome Measures

Name	Time	Method
Amount of Tobacco Product Used	6 weeks	Total number of cigarettes smoked and puffs of e-cigarettes used

Secondary Outcome Measures

Name	Time	Method
How Much of Each Product is Obtained From the "Experimental Marketplace"	6 weeks	Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"
Motivation to Quit Smoking Cigarettes	6 weeks	Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time

Trial Locations

Locations (1)

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