drugset / Trial / NCT05159934
Nicotine Differences in Smokers
RandomizedCrossoverDouble-blindHealth-services research
Summary
The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of nicotine doses that are delivered by cigarettes with very low to regular nicotine content. These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration with a 28 sec interval between each dose.
Timeline
- Start
- 2022-02-16
- Primary completion
- 2023-07-19
- Completion
- 2023-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nicotine | Unknown | 0.0125 mg | Intravenous |
| Comparator | Nicotine | Unknown | 0.025 mg | Intravenous |
| Comparator | Nicotine | Unknown | 0.05 mg | Intravenous |
| Comparator | Nicotine | Unknown | 0.1 mg | Intravenous |