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Impact of Switching to Non-Menthol Cigarettes Among Smokers

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ClinicalTrials.gov Identifier: NCT03075839
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Other: Cigarette Brand Switching Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Switching to Non-Menthol Cigarettes Among Smokers
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Arm Intervention/treatment
Experimental: Cigarette Brand Switching
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes
Other: Cigarette Brand Switching
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes




Primary Outcome Measures :
  1. Total number of cigarettes smoked [ Time Frame: Week 3 ]
    Self-reported total number of cigarettes smoked per day when smoking non-menthol cigarettes (Week 3)


Secondary Outcome Measures :
  1. Total number of cigarettes smoked [ Time Frame: Week 1 ]
    Self-reported total number of cigarettes smoked per day when smoking menthol cigarettes

  2. Smoking Satisfaction [ Time Frame: Week 1 ]
    Self-reported subjective ratings of satisfaction when smoking menthol cigarettes

  3. Smoking Satisfaction [ Time Frame: Week 3 ]
    Self-reported subjective ratings of satisfaction when smoking non-menthol cigarettes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075839


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Krysten Bold, Ph.D. Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03075839     History of Changes
Other Study ID Numbers: 2000020334
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No