可行性研究 - 过滤器通风

实验性的：Menthol Cigarette Smokers Group 1

Smokers regularly using menthol cigarettes (at least 80% of the time ) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes.

其他：Ventilated non-menthol cigarettes

4 week intervention where participants will be using ventilated non-menthol cigarettes.

Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.

有源比较器：Menthol Cigarettes Smokers Group 2

Smokers regularly using menthol cigarettes (at least 80% of the time ) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes.

其他：Minimally Ventilated non-menthol cigarettes

4 week intervention where participants will be using minimally ventilated non-menthol cigarettes.

Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.

Percentage of Participants That Dropped Out

Percentage of Participants that dropped out by week 4.

Feasibility of Approach - Data Collection

Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and interview

Cigarettes Smoked Per Day

Change in mean Cigarettes Per Day (CPD) based on 7 day ITR data before visit. Randomized participants (low vs moderate FV), between-group difference in change in cigarettes per day from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cigarettes per day (CPD) was calculated as the mean number of cigarettes smoked per day based on daily self-reported cigarette use collected via interactive text response (ITR) surveys. Change scores were computed as the difference between the mean CPD at Week 4 and the mean CPD at baseline for each participant, and group differences reflect the between-arm difference in these change scores.

Cotinine Change

Change in cotinine from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in cotinine from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cotinine was measured from blood samples collected using volumetric absorptive micro sampling (VAMS) and analyzed using liquid chromatography-mass spectrometry. Due to skewness, cotinine values were log-transformed, and change was calculated as the log ratio of Week 4 to baseline levels. Group differences represent the between-arm difference in these log-transformed changes.

Carbon Monoxide Changes

Change in Carbon Monoxide from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in carbon monoxide from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Exhaled carbon monoxide (ppm) was measured remotely using a portable CO monitor during scheduled study visits. Change scores were calculated as Week 4 minus baseline CO levels for each participant, and group differences represent the between-arm difference in these change scores.

Quit Attempts

Number of 24 hour quit attempts analyzed using regression estimate. Randomized participants (low vs moderate FV), between-group difference in quit attempt from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups.