Smoking Cessation in Menthol Flavored Cigarette Smokers

NCT ID: NCT02342327

Last Updated: 2021-04-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-28

Study Completion Date

2018-07-11

Brief Summary

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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

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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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Continue smoking menthol cigarettes

Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking

Group Type OTHER

continue smoking menthol cigarettes prior to cessation attempt

Intervention Type OTHER

Switch to non-menthol cigarettes

Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking

Group Type OTHER

switch to non-menthol cigarettes prior to cessation attempt

Intervention Type OTHER

Interventions

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switch to non-menthol cigarettes prior to cessation attempt

Intervention Type OTHER

continue smoking menthol cigarettes prior to cessation attempt

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kotlyar, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

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, Okuyemi KS, Mills AM, Hatsukami DK. Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. Nicotine Tob Res. 2021 Oct 7;23(11):1921-1927. doi: 10.1093/ntr/ntab090.

Reference Type DERIVED
PMID: 33983396 (View on PubMed)

Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on time to lapse of switching menthol smokers to non-menthol cigarettes prior to a cessation attempt: a pilot study. Tob Control. 2021 Sep;30(5):574-577. doi: 10.1136/tobaccocontrol-2020-055689. Epub 2020 Jul 27.

Reference Type DERIVED
PMID: 32719011 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1406M51364

Identifier Type: -

Identifier Source: org_study_id

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