Smoking Topography and Harm Exposure in Menthol Cigarettes

NCT ID: NCT01329263

Last Updated: 2015-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.

Detailed Description

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This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.

Conditions

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Cigarette Smoking Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nonmenthol

Participants switch from menthol to non-menthol cigarettes.

Group Type EXPERIMENTAL

Menthol to non-menthol

Intervention Type OTHER

Switch from smoking menthol to non-menthol cigarettes.

Menthol

Participants smoke own brand of menthol cigarettes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Menthol to non-menthol

Switch from smoking menthol to non-menthol cigarettes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Self-report smoking daily cigarettes
* Self-report smoking menthol flavored cigarettes
* Not currently trying to quit or planning to quit in the next 2 months.
* Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette
* Self-report smoking only filtered commercially made cigarettes

Exclusion Criteria

* Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week
* Self report using any nicotine replacement products or nicotine-containing products other than cigarettes
* Self-report substance use disorders in the last 5 years
* Self-report current Axis I psychiatric disorders
* Self-report past history of Axis I psychiatric disorders other than depression
* Self-report myocardial infarction, angina or abnormal rhythms requiring medication
* Self-report use of select medications and illicit drugs within past six months
* Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating
* Provide a baseline carbon monoxide (CO) reading \< 10 ppm at initial session
* Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Andrew Strasser

Associate Professor Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew A Strasser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18.

Reference Type BACKGROUND
PMID: 23334588 (View on PubMed)

Other Identifiers

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R01CA120594

Identifier Type: NIH

Identifier Source: secondary_id

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R01CA130961

Identifier Type: NIH

Identifier Source: secondary_id

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P30ES013508

Identifier Type: NIH

Identifier Source: secondary_id

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P50CA143187

Identifier Type: NIH

Identifier Source: secondary_id

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812369

Identifier Type: -

Identifier Source: org_study_id

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