Trial Outcomes & Findings for Impact of Switching to Non-Menthol Cigarettes Among Smokers (NCT NCT03075839)

NCT ID: NCT03075839

Last Updated: 2023-03-02

Results Overview

Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Menthol smoking (Week 2), Non-menthol smoking (Week 4)
• Results posted on: 2023-03-02

Participant Flow

Participant milestones

Measure	Cigarette Brand Switching Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Overall Study STARTED	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Cigarette Brand Switching Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Overall Study Lost to Follow-up	4

Baseline Characteristics

Impact of Switching to Non-Menthol Cigarettes Among Smokers

Baseline characteristics by cohort

Measure	Cigarette Brand Switching n=33 Participants Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Age, Continuous	35.6 years STANDARD_DEVIATION 11.6 • n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	6 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non Hispanic Black	13 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non Hispanic White	11 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	3 Participants n=93 Participants
Region of Enrollment United States	33 participants n=93 Participants

PRIMARY outcome

Timeframe: Menthol smoking (Week 2), Non-menthol smoking (Week 4)

Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes

Outcome measures

Measure	Cigarette Brand Switching n=29 Participants Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Total Number of Cigarettes Smoked	2.2 cigarettes per day Standard Deviation 3.2

SECONDARY outcome

Timeframe: Week 4 (non-menthol)

Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence.

Outcome measures

Measure	Cigarette Brand Switching n=29 Participants Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Nicotine Dependence	36.8 score on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: Week 4 (non-menthol)

Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item "how important is quitting smoking to you?" from 1 "not at all" to 10 "extremely".

Outcome measures

Measure	Cigarette Brand Switching n=29 Participants Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Quitting Interest	5.4 units on a scale Standard Deviation 2.5

Adverse Events

Cigarette Brand Switching

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

Krysten Bold

Yale University

Phone: 203-974-7603

Email: Krysten.bold@yale.edu

Results disclosure agreements

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