drugset / Trial / NCT05159934

Nicotine Differences in Smokers

NCT05159934

Phase 1 Completed 11 enrolled Yale University
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

EvaluationDrugModalityDoseRoute
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

Indications