Impact of Switching to Non-Menthol Cigarettes Among Smokers

NCT ID: NCT03075839

Last Updated: 2023-03-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2018-09-01

Brief Summary

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This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.

Detailed Description

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The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).

Conditions

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Tobacco Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cigarette Brand Switching

Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes

Group Type EXPERIMENTAL

Cigarette Brand Switching

Intervention Type OTHER

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks

Interventions

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Cigarette Brand Switching

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 or older
* Able to read English
* Cigarette smoker

Exclusion Criteria

* Seeking smoking cessation treatment
* Serious psychiatric or medical condition
* Use of other drugs
* Unable or unwilling to complete study protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krysten Bold, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Bold KW, Jatlow P, Fucito LM, Eid T, Krishnan-Sarin S, O'Malley S. Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Tob Control. 2020 Nov;29(6):624-630. doi: 10.1136/tobaccocontrol-2019-055154. Epub 2019 Nov 4.

Reference Type DERIVED
PMID: 31685586 (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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1P50DA036151-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000020334

Identifier Type: -

Identifier Source: org_study_id

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