Trial Outcomes & Findings for Smoking Cessation in Menthol Flavored Cigarette Smokers (NCT NCT02342327)

NCT ID: NCT02342327

Last Updated: 2021-04-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-04-28

Participant Flow

Participant milestones

Measure	Continue Smoking Menthol Cigarettes 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	Switch to Non-menthol Cigarettes 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
Overall Study STARTED	60	62
Overall Study Completed Quit Day Visit	54	53
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	21	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smoking Cessation in Menthol Flavored Cigarette Smokers

Baseline characteristics by cohort

Measure	Continue Smoking Menthol Cigarettes n=60 Participants 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	Switch to Non-menthol Cigarettes n=62 Participants 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 n=122 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 10 • n=5 Participants	45 years STANDARD_DEVIATION 11 • n=7 Participants	46 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	62 participants n=7 Participants	122 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who attended the quit day visit

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

Outcome measures

Measure	Continue Smoking Menthol Cigarettes n=54 Participants 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	Switch to Non-menthol Cigarettes n=53 Participants 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
Time to Lapse	1.07 days Interval 0.94 to 2.7	2.55 days Interval 1.65 to 4.46

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Continue Smoking Menthol Cigarettes n=54 Participants 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	Switch to Non-menthol Cigarettes n=53 Participants 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
Time to Relapse	7 days Interval 2.0 to 32.0	42 days Interval 10.0 to 84.0

Adverse Events

Continue Smoking Menthol Cigarettes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Switch to Non-menthol Cigarettes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Kotlyar

University of Minnesota

Phone: 612-625-1160

Email: kotly001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place