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

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use Disorder

Treatments: Other: Menthol ban on cigarettes; Other: No menthol ban; Other: Menthol ban on cigarettes and e-cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03402243

R03DA045150 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Menthol ban only for cigarettes

Experimental group

Description:

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

Treatment:

Other: Menthol ban on cigarettes

Menthol ban for cigarettes and e-cigarettes

Experimental group

Description:

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

Treatment:

Other: Menthol ban on cigarettes and e-cigarettes

No Menthol Ban

Other group

Description:

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

Treatment:

Other: No menthol ban