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Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

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ClinicalTrials.gov Identifier: NCT04009850
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

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

Detailed Description:
The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking
Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: Menthol e-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Other: Cigarette Brand Switching
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes

Experimental: Tobacco e-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
Other: E-cigarette Flavor
Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes




Primary Outcome Measures :
  1. Total number of cigarettes smoked [ Time Frame: Week 6 ]
    Self-reported total number of cigarettes smoked per day (Timeline Follow Back)


Secondary Outcome Measures :
  1. E-cigarette use [ Time Frame: Week 6 ]
    Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)

  2. Tobacco Product Satisfaction [ Time Frame: Week 6 ]
    Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire)

  3. Motivation/Confidence to Quit Smoking [ Time Frame: Week 6 ]
    Self-reported motivation/confidence to quit smoking cigarettes (Contemplation Ladder)

  4. Nicotine dependence [ Time Frame: Week 6 ]
    Self-reported nicotine dependence (NIH Promis Dependence Measure)



Information from the National Library of Medicine

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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): NCT04009850


Contacts
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Contact: Krysten Bold, Ph.D. 203-974-7603 krysten.bold@yale.edu
Contact: Heather LaVallee 203-974-7373

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Krysten Bold, Ph.D.         
Principal Investigator: Krysten Bold, Ph.D.         
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

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04009850     History of Changes
Other Study ID Numbers: 2000025572
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 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
Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents