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

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ClinicalTrials.gov Identifier: NCT03164668
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: menthol flavored e-cigarette Other: tobacco flavored e-cigarette Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
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

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

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

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




Primary Outcome Measures :
  1. number of cigarettes smoked [ Time Frame: 1 month ]
  2. number of e-cigarettes used [ Time Frame: 1 month ]


Information from the National Library of Medicine

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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:

  • 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


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): NCT03164668


Locations
United States, Minnesota
Clinical and Translational Sciences Institute Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael Kotlyar, PharmD    612-625-1160    kotly001@umn.edu   
Principal Investigator: Michael Kotlyar, PharmD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03164668     History of Changes
Other Study ID Numbers: RC-2016-0004
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Menthol
Antipruritics
Dermatologic Agents