Filter Ventilation
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | October 25, 2018 |
| End Date: | September 30, 2022 |
| Contact: | Joni Jensen, MPH |
| Email: | jense010@umn.edu |
| Phone: | 612-6245178 |
Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
The goal of this study is to determine the biomarkers of exposure and harm as well as the
pattern of product purchase when ventilated vs. unventilated cigarettes are available in the
marketplace with and without alternative nicotine delivery systems (ANDS).
The primary aim of this study is to examine the effects of cigarette filter ventilation on
biomarkers of toxicant exposure and toxicity and smoking behavior (cigs/day), with or without
the availability of ANDS.
pattern of product purchase when ventilated vs. unventilated cigarettes are available in the
marketplace with and without alternative nicotine delivery systems (ANDS).
The primary aim of this study is to examine the effects of cigarette filter ventilation on
biomarkers of toxicant exposure and toxicity and smoking behavior (cigs/day), with or without
the availability of ANDS.
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 10 week experimental trial with one
week of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the
study cigarettes in the marketplace. 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.
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 10 week experimental trial with one
week of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the
study cigarettes in the marketplace. 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.
Inclusion Criteria:
- At least 18 years of age
- Biochemically confirmed regular cigarette smoker
Exclusion Criteria:
- Unstable health
- Unstable medications
- Pregnant or nursing
We found this trial at
2
sites
717 Delaware Street Southeast
Minneapolis, Minnesota 55414
Minneapolis, Minnesota 55414
Principal Investigator: Dorothy K Hatsukami, PhD
Phone: 612-624-5178
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Columbus, Ohio 43210
Principal Investigator: Peter Shields, MD
Phone: 614-366-4542
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