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Addiction Potential of Very Low Nicotine Filtered Little Cigars (LOWFLC)
The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question\[s\] it aims to answer are: Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will * fill several surveys * provide blood samples * perform breathing tests * complete smoking sessions using either their own cigars or the study cigars.
Details
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 50 |
| Start date | 2025-02-13 |
| Completion | 2028-01 |
Conditions
- Smoking (Tobacco) Addiction
Interventions
- Reduced Nicotine Content Cigars
- Normal nicotine content cigar
- Usual brand cigar
Primary outcomes
- Drug self-administration- Puff topography- total puff volume — During session 65 minute puffing session
Derived from puff topography, total puff volume indicates the total amount of smoke inhaled during the smoking session. Units: mL - Forced expiratory volume in 1 second — Change from 0 to 65 minutes
Spirometry will be completed before and after a 65 min smoking session - Nicotine — Change from 0 to 5 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 5 minutes after the smoking session - Nicotine — Change from 0 to 65 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 65 minutes after the smoking session - Carbon monoxide boost — Change from 0 to 5 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and 5 minutes after the smoking session - Carbon monoxide boost — Change from 0 to 65 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and after the smoking session
Countries
United States