search
Back to results

Smoking Cessation in Menthol Flavored Cigarette Smokers

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
switch to non-menthol cigarettes prior to cessation attempt
continue smoking menthol cigarettes prior to cessation attempt
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 SexesDoes not accept 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
  • 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

Sites / Locations

  • Clinical and Translational Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Continue smoking menthol cigarettes

Switch to non-menthol cigarettes

Arm Description

Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking

Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking

Outcomes

Primary Outcome Measures

Time to Lapse
Time from smoking cessation until first lapse (i.e. a cigarette is smoked)

Secondary Outcome Measures

Time to Relapse
Days from the quit attempt until the first of seven consecutive smoking days

Full Information

First Posted
January 14, 2015
Last Updated
April 27, 2021
Sponsor
University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT02342327
Brief Title
Smoking Cessation in Menthol Flavored Cigarette Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2014 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
July 11, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continue smoking menthol cigarettes
Arm Type
Other
Arm Description
Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking
Arm Title
Switch to non-menthol cigarettes
Arm Type
Other
Arm Description
Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking
Intervention Type
Other
Intervention Name(s)
switch to non-menthol cigarettes prior to cessation attempt
Intervention Type
Other
Intervention Name(s)
continue smoking menthol cigarettes prior to cessation attempt
Primary Outcome Measure Information:
Title
Time to Lapse
Description
Time from smoking cessation until first lapse (i.e. a cigarette is smoked)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to Relapse
Description
Days from the quit attempt until the first of seven consecutive smoking days
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kotlyar, PharmD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
33983396
Citation
Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. Nicotine Tob Res. 2021 Oct 7;23(11):1921-1927. doi: 10.1093/ntr/ntab090.
Results Reference
derived
PubMed Identifier
32719011
Citation
Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on time to lapse of switching menthol smokers to non-menthol cigarettes prior to a cessation attempt: a pilot study. Tob Control. 2021 Sep;30(5):574-577. doi: 10.1136/tobaccocontrol-2020-055689. Epub 2020 Jul 27.
Results Reference
derived

Learn more about this trial

Smoking Cessation in Menthol Flavored Cigarette Smokers

We'll reach out to this number within 24 hrs