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Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
menthol flavored e-cigarette
tobacco flavored e-cigarette
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:

  • Self identify as African American
  • smoke primarily menthol cigarettes
  • be between the ages of 18 and 64
  • smoke a minimum number of cigarettes per day
  • agree to abstain from menthol cigarettes for an 8 week period

Exclusion Criteria:

  • current unstable medical / psychiatric condition
  • regular use any form of nicotine or tobacco other than cigarettes
  • are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate

Sites / Locations

  • Clinical and Translational Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Usual cigs; menthol e-cig then tobacco e-cigs

Usual cigs; tobacco e-cig then menthol e-cigs

avoid menthol cigs; menthol e-cig then tobacco e-cigs

avoid menthol cigs; tobacco e-cig then menthol e-cigs

Arm Description

Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes

Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes

Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes

Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes

Outcomes

Primary Outcome Measures

number of cigarettes smoked
number of e-cigarettes used

Secondary Outcome Measures

Full Information

First Posted
May 22, 2017
Last Updated
December 1, 2020
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03164668
Brief Title
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Official Title
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

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
The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual cigs; menthol e-cig then tobacco e-cigs
Arm Type
Other
Arm Description
Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes
Arm Title
Usual cigs; tobacco e-cig then menthol e-cigs
Arm Type
Other
Arm Description
Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes
Arm Title
avoid menthol cigs; menthol e-cig then tobacco e-cigs
Arm Type
Other
Arm Description
Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes
Arm Title
avoid menthol cigs; tobacco e-cig then menthol e-cigs
Arm Type
Other
Arm Description
Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes
Intervention Type
Other
Intervention Name(s)
menthol flavored e-cigarette
Intervention Description
menthol flavored e-cigarette
Intervention Type
Other
Intervention Name(s)
tobacco flavored e-cigarette
Intervention Description
tobacco flavored e-cigarette
Primary Outcome Measure Information:
Title
number of cigarettes smoked
Time Frame
1 month
Title
number of e-cigarettes used
Time Frame
1 month

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: Self identify as African American smoke primarily menthol cigarettes be between the ages of 18 and 64 smoke a minimum number of cigarettes per day agree to abstain from menthol cigarettes for an 8 week period Exclusion Criteria: current unstable medical / psychiatric condition regular use any form of nicotine or tobacco other than cigarettes are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not be eligible to participate
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

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Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes

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