Smoking Cessation in Menthol Flavored Cigarette Smokers

April 27, 2021 updated by: University of Minnesota
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

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

No

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
  • 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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Lapse
Time Frame: 6 months
Time from smoking cessation until first lapse (i.e. a cigarette is smoked)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Relapse
Time Frame: 6 months
Days from the quit attempt until the first of seven consecutive smoking days
6 months

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Michael Kotlyar, PharmD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 28, 2014

Primary Completion (Actual)

July 11, 2018

Study Completion (Actual)

July 11, 2018

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1406M51364

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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