Smoking, Tobacco Use
Conditions
Keywords
Cigarette smoking, Filter Ventilation
Brief summary
Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.
Detailed description
This randomized, open label, controlled multi-site study will simulate a real world tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products. Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS. Smokers will undergo an in person screening and then a 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. The experimental period will simulate a real world environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money. Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial.
Interventions
OTHERVentilated cigarettes only
Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
OTHERUnventilated cigarettes only
Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
OTHERAccess to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems
Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
OTHERAccess to Experimental Marketplace: Unventilated cigarettes + ANDS
Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.
Sponsors
Ohio State University
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Phase III randomized, open label, multi-center study assessing the impact of filter ventilation. Assigned to ventilated or unventilated cigarettes and either access to ANDS in an experimental marketplace, or no access to ANDS or any other products.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Biochemically confirmed regular cigarette smoker
Exclusion criteria
* Unstable health * Unstable medications * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total NNAL at Week 8 Visit | Week 8 | The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00) |
| Mean CPD based on 7 day IVR before week 8 visit. | Week 8 | The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline | Week 8 | Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT) |
| Number of cigarette-free days | Week 8 | number of cigarette-free days based on no cigarettes smoked in the previous day on IVR (dropouts with no IVR data are assumed to be smoking) |
Countries
United States
Outcome results
None listed