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

NCT ID: NCT03402243

Last Updated: 2021-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2020-03-25

Brief Summary

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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

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Menthol ban only for 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

Group Type EXPERIMENTAL

Menthol ban on cigarettes

Intervention Type OTHER

Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes

Menthol ban for 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

Group Type EXPERIMENTAL

Menthol ban on cigarettes and e-cigarettes

Intervention Type OTHER

Participants will have neither menthol flavored cigarettes or e-cigarettes available

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

Group Type OTHER

No menthol ban

Intervention Type OTHER

Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available

Interventions

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Menthol ban on cigarettes

Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes

Intervention Type OTHER

Menthol ban on cigarettes and e-cigarettes

Participants will have neither menthol flavored cigarettes or e-cigarettes available

Intervention Type OTHER

No menthol ban

Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical and Translational Sciences Institute

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Hatsukami DK. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes. Nicotine Tob Res. 2022 Aug 6;24(9):1448-1457. doi: 10.1093/ntr/ntac107.

Reference Type DERIVED
PMID: 35430631 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R03DA045150

Identifier Type: NIH

Identifier Source: secondary_id

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R03DA045150

Identifier Type: NIH

Identifier Source: org_study_id

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