NCT02342327

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 28, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

January 14, 2015

Results QC Date

March 10, 2021

Last Update Submit

April 27, 2021

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Time to Lapse

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

    6 months

Secondary Outcomes (1)

  • Time to Relapse

    6 months

Study Arms (2)

Continue smoking menthol cigarettes

OTHER

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

OTHER

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

Interventions

switch to non-menthol cigarettes prior to cessation attemptOTHER
Switch to non-menthol cigarettes
continue smoking menthol cigarettes prior to cessation attemptOTHER
Continue smoking menthol cigarettes

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

  • 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.

    PMID: 33983396DERIVED

  • 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.

    PMID: 32719011DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Michael Kotlyar
Organization
University of Minnesota
kotly001@umn.edu
612-625-1160

Study Officials

  • Michael Kotlyar, PharmD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

October 28, 2014

Primary Completion

July 11, 2018

Study Completion

July 11, 2018

Last Updated

April 28, 2021

Results First Posted

April 28, 2021

Record last verified: 2021-04

Locations

US(1)