Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes

NCT ID: NCT03164668

Last Updated: 2024-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2019-11-26

Brief Summary

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The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes

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

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual cigs; menthol e-cig then tobacco e-cigs

Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes

Group Type OTHER

menthol flavored e-cigarette

Intervention Type OTHER

menthol flavored e-cigarette

tobacco flavored e-cigarette

Intervention Type OTHER

tobacco flavored e-cigarette

Usual cigs; tobacco e-cig then menthol e-cigs

Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes

Group Type OTHER

menthol flavored e-cigarette

Intervention Type OTHER

menthol flavored e-cigarette

tobacco flavored e-cigarette

Intervention Type OTHER

tobacco flavored e-cigarette

avoid menthol cigs; menthol e-cig then tobacco e-cigs

Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes

Group Type OTHER

menthol flavored e-cigarette

Intervention Type OTHER

menthol flavored e-cigarette

tobacco flavored e-cigarette

Intervention Type OTHER

tobacco flavored e-cigarette

avoid menthol cigs; tobacco e-cig then menthol e-cigs

Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes

Group Type OTHER

menthol flavored e-cigarette

Intervention Type OTHER

menthol flavored e-cigarette

tobacco flavored e-cigarette

Intervention Type OTHER

tobacco flavored e-cigarette

Interventions

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menthol flavored e-cigarette

menthol flavored e-cigarette

Intervention Type OTHER

tobacco flavored e-cigarette

tobacco flavored e-cigarette

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
* agree to abstain from menthol cigarettes for an 8 week period

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

Yes

Sponsors

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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

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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1609M94682

Identifier Type: -

Identifier Source: org_study_id

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