Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 164
- Locations
- 4
- Primary Endpoint
- Change in Cigarettes Per Day (CPD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Masking Description
Single blind
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in Cigarettes Per Day (CPD)
Time Frame: 7 days prior to week 0 visit and 7 days prior to week 6 visit
Change in cigarettes per day, daily diary reviewed data.
Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported