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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04009850
Recruitment Status : Suspended (Temporarily suspended due to COVID-19 pandemic.)
First Posted : July 5, 2019
Last Update Posted : May 22, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
Total number of cigarettes smoked [ Time Frame: Week 6 ]
Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Total number of cigarettes smoked [ Time Frame: Week 6 ]
Self-reported total number of cigarettes smoked per day
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • E-cigarette use [ Time Frame: Week 6 ]
    Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)
  • Tobacco Product Satisfaction [ Time Frame: Week 6 ]
    Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire)
  • Motivation/Confidence to Quit Smoking [ Time Frame: Week 6 ]
    Self-reported motivation/confidence to quit smoking cigarettes (Contemplation Ladder)
  • Nicotine dependence [ Time Frame: Week 6 ]
    Self-reported nicotine dependence (NIH Promis Dependence Measure)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • E-cigarette use [ Time Frame: Week 6 ]
    Self-reported e-cigarette use compared by e-cigarette flavor
  • Tobacco Product Satisfaction [ Time Frame: Week 6 ]
    Self-reported subjective ratings of satisfaction with tobacco products
  • Motivation/Confidence to Quit Smoking [ Time Frame: Week 6 ]
    Self-reported motivation/confidence to quit smoking cigarettes
  • Nicotine dependence [ Time Frame: Week 6 ]
    Self-reported nicotine dependence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Official Title  ICMJE Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Tobacco Use
Intervention  ICMJE
  • Other: Cigarette Brand Switching
    Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
  • Other: E-cigarette Flavor
    Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Study Arms  ICMJE
  • Experimental: Menthol e-cigarette
    Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
    Intervention: Other: Cigarette Brand Switching
  • Experimental: Tobacco e-cigarette
    Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
    Intervention: Other: E-cigarette Flavor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009850
Other Study ID Numbers  ICMJE 2000025572
2U54DA036151-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Food and Drug Administration (FDA)
Investigators  ICMJE
Principal Investigator: Krysten Bold, Ph.D. Yale University
PRS Account Yale University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP