Smoking Cessation in Menthol Flavored Cigarette Smokers

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT02342327
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.4
• Patients Per Site Per Month: 2.7

Study Details

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

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: Oct 28, 2014
• Actual Primary Completion Date: Jul 11, 2018
• Actual Study Completion Date: Jul 11, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to Lapse [6 months]

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

Secondary Outcome Measures

1. Time to Relapse [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical and Translational Sciences Institute	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 26, 2017

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02342327
• Other Study ID Numbers: 1406M51364
• First Posted: Jan 19, 2015
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Tobacco Use Disorder; Menthol

Study Results

Participant Flow

Arm/Group Title	Continue Smoking Menthol Cigarettes	Switch to Non-menthol Cigarettes
Arm/Group Description	Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt	Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt
Period Title: Overall Study
STARTED	60	62
Completed Quit Day Visit	54	53
COMPLETED	39	40
NOT COMPLETED	21	22

Baseline Characteristics

Arm/Group Title	Continue Smoking Menthol Cigarettes	Switch to Non-menthol Cigarettes	Total
Arm/Group Description	Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt	Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt	Total of all reporting groups
Overall Participants	60	62	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (10)	45 (11)	46 (11)
Sex: Female, Male (Count of Participants)
Female	22 36.7%	23 37.1%	45 36.9%
Male	38 63.3%	39 62.9%	77 63.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	60 100%	62 100%	122 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	60 100%	62 100%	122 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who attended the quit day visit

Arm/Group Title	Continue Smoking Menthol Cigarettes	Switch to Non-menthol Cigarettes
Arm/Group Description	Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt	Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt
Measure Participants	54	53
Median (95% Confidence Interval) [days]	1.07	2.55

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Continue Smoking Menthol Cigarettes
	Comments	Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continue Smoking Menthol Cigarettes	Switch to Non-menthol Cigarettes
Arm/Group Description	Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt	Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt
Measure Participants	54	53
Median (95% Confidence Interval) [days]	7	42

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Continue Smoking Menthol Cigarettes
	Comments	Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95%; 0.42 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	For the duration of each participant's participation (up to 7 months for each participant)
Arm/Group Title	Continue Smoking Menthol Cigarettes		Switch to Non-menthol Cigarettes
Arm/Group Description	Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt		Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt
All Cause Mortality
	Continue Smoking Menthol Cigarettes		Switch to Non-menthol Cigarettes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/62 (0%)
Serious Adverse Events
	Continue Smoking Menthol Cigarettes		Switch to Non-menthol Cigarettes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Continue Smoking Menthol Cigarettes		Switch to Non-menthol Cigarettes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.