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Smoking Cessation in Menthol Flavored Cigarette Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342327
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: switch to non-menthol cigarettes prior to cessation attempt Other: continue smoking menthol cigarettes prior to cessation attempt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : October 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
Drug Information available for: Menthol

Arm Intervention/treatment
Continue smoking menthol cigarettes
Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking
Other: continue smoking menthol cigarettes prior to cessation attempt
Switch to non-menthol cigarettes
Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking
Other: switch to non-menthol cigarettes prior to cessation attempt



Primary Outcome Measures :
  1. Time to lapse [ Time Frame: 6 months ]
    Time from smoking cessation until first lapse (i.e. a cigarette is smoked)



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:   No
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
  • express an interest in quitting smoking

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): NCT02342327


Locations
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United States, Minnesota
Clinical and Translational Sciences Institute Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael Kotlyar    612-625-1160    kotly001@umn.edu   
Principal Investigator: Michael Kotlyar, PharmD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Michael Kotlyar, PharmD University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02342327    
Other Study ID Numbers: 1406M51364
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Menthol
Antipruritics
Dermatologic Agents