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

December 1, 2020 updated by: University of Minnesota
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical and Translational Sciences Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual cigs; menthol e-cig then tobacco e-cigs
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
Other: menthol flavored e-cigarette
menthol flavored e-cigarette
Other: tobacco flavored e-cigarette
tobacco flavored e-cigarette
Other: Usual cigs; tobacco e-cig then menthol e-cigs
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
Other: menthol flavored e-cigarette
menthol flavored e-cigarette
Other: tobacco flavored e-cigarette
tobacco flavored e-cigarette
Other: avoid menthol cigs; menthol e-cig then tobacco e-cigs
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
Other: menthol flavored e-cigarette
menthol flavored e-cigarette
Other: tobacco flavored e-cigarette
tobacco flavored e-cigarette
Other: avoid menthol cigs; tobacco e-cig then menthol e-cigs
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
Other: menthol flavored e-cigarette
menthol flavored e-cigarette
Other: tobacco flavored e-cigarette
tobacco flavored e-cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of cigarettes smoked
Time Frame: 1 month
1 month
number of e-cigarettes used
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 26, 2019

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1609M94682

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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