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Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

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ClinicalTrials.gov Identifier: NCT03402243
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: Menthol ban on cigarettes Other: Menthol ban on cigarettes and e-cigarettes Other: No menthol ban Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Menthol ban only for cigarettes
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Other: Menthol ban on cigarettes
Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes

Experimental: Menthol ban for cigarettes and e-cigarettes
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Other: Menthol ban on cigarettes and e-cigarettes
Participants will have neither menthol flavored cigarettes or e-cigarettes available

No Menthol Ban
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Other: No menthol ban
Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available




Primary Outcome Measures :
  1. Amount of each tobacco product used per week [ Time Frame: 6 weeks ]
    Number of cigarettes smoked; amount of e-liquid used; number of medicinal nicotine pieces used


Secondary Outcome Measures :
  1. How much of each product is obtained from the "experimental marketplace" [ Time Frame: 6 weeks ]
    Number of packs of cigarettes obtained; amount of e-liquid obtained; number of medicinal nicotine pieces obtained from the "experimental marketplace"

  2. motivation to quit smoking cigarettes [ Time Frame: 6 weeks ]
    Based on a 10 point scale assessing motivation to quit smoking



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between the ages of 18 and 64
  • Purchase exclusively menthol cigarettes
  • Not currently motivated to quit smoking
  • Smoking a minimum number of cigarettes per day

Exclusion Criteria:

  • Report a serious, unstable medical or psychiatric condition
  • Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
  • Have used any smoking cessation therapy during the past month
  • Regularly use any form of tobacco other than cigarettes
  • Are pregnant or breast feeding or planning to become pregnant or breast feed during the study

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): NCT03402243


Locations
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United States, Minnesota
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03402243     History of Changes
Other Study ID Numbers: R03DA045150 ( U.S. NIH Grant/Contract )
R03DA045150 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No identifiable information will be shared with other researchers

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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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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Menthol
Antipruritics
Dermatologic Agents