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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Menthol ban on cigarettes
Menthol ban on cigarettes and e-cigarettes
No menthol ban
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical and Translational Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Menthol ban only for cigarettes

Menthol ban for cigarettes and e-cigarettes

No Menthol Ban

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Amount of Tobacco Product Used
Total number of cigarettes smoked and puffs of e-cigarettes used

Secondary Outcome Measures

How Much of Each Product is Obtained From the "Experimental Marketplace"
Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"
Motivation to Quit Smoking Cigarettes
Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time

Full Information

First Posted
January 9, 2018
Last Updated
July 16, 2021
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03402243
Brief Title
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Official Title
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menthol ban only for cigarettes
Arm Type
Experimental
Arm Description
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
Arm Title
Menthol ban for cigarettes and e-cigarettes
Arm Type
Experimental
Arm Description
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
Arm Title
No Menthol Ban
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Menthol ban on cigarettes
Intervention Description
Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
Intervention Type
Other
Intervention Name(s)
Menthol ban on cigarettes and e-cigarettes
Intervention Description
Participants will have neither menthol flavored cigarettes or e-cigarettes available
Intervention Type
Other
Intervention Name(s)
No menthol ban
Intervention Description
Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
Primary Outcome Measure Information:
Title
Amount of Tobacco Product Used
Description
Total number of cigarettes smoked and puffs of e-cigarettes used
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
How Much of Each Product is Obtained From the "Experimental Marketplace"
Description
Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"
Time Frame
6 weeks
Title
Motivation to Quit Smoking Cigarettes
Description
Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Clinical and Translational Sciences Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No identifiable information will be shared with other researchers
Citations:
PubMed Identifier
35430631
Citation
Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Hatsukami DK. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes. Nicotine Tob Res. 2022 Aug 6;24(9):1448-1457. doi: 10.1093/ntr/ntac107.
Results Reference
derived

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

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