Tobacco Use
Conditions
Keywords
cigarette smoking, filter ventilation
Brief summary
The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette. The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.
Detailed description
This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples. Subjects (N=164; N=82 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed. Biomarker samples will be assessed for total nicotine equivalents, tobacco specific nitrosamines and volatile organic compound.
Interventions
Ventilated Cigarette Filter
Unventilated Cigarette Filter
Sponsors
Study design
Masking description
Single blind
Intervention model description
Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation
Eligibility
Inclusion criteria
* At least 21 years of age * Biochemically confirmed regular cigarette smoker * Daily smoker, 5-30 cigarettes per day. * Usual brand cigarettes 16-36% ventilation
Exclusion criteria
* Unstable health * Unstable medications * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine] | 6 weeks randomized intervention | Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS). |
| Change in Cigarettes Per Day (CPD) | 7 days prior to week 0 visit and 7 days prior to week 6 visit | Change in cigarettes per day, daily diary reviewed data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventilated Cigarette Filter Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter | 80 |
| Unventilated Cigarette Filter Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter | 84 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 6 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Total | Ventilated Cigarette Filter | Unventilated Cigarette Filter |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 161 Participants | 78 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants | 76 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 142 Participants | 69 Participants | 73 Participants |
| Region of Enrollment United States | 164 participants | 80 participants | 84 participants |
| Sex: Female, Male Female | 100 Participants | 52 Participants | 48 Participants |
| Sex: Female, Male Male | 64 Participants | 28 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 84 |
| other Total, other adverse events | 73 / 80 | 74 / 84 |
| serious Total, serious adverse events | 1 / 80 | 0 / 84 |
Outcome results
Change in Cigarettes Per Day (CPD)
Change in cigarettes per day, daily diary reviewed data.
Time frame: 7 days prior to week 0 visit and 7 days prior to week 6 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventilated Cigarette Filter | Change in Cigarettes Per Day (CPD) | -0.39 Cigarettes per day | Standard Deviation 2.73 |
| Unventilated Cigarette Filter | Change in Cigarettes Per Day (CPD) | -0.17 Cigarettes per day | Standard Deviation 3.41 |
Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]
Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Time frame: 6 weeks randomized intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ventilated Cigarette Filter | Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine] | 0.97 ng/g creatinine |
| Unventilated Cigarette Filter | Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine] | 1.05 ng/g creatinine |