NCT05159934

Nicotine Differences in Smokers

Nicotine Discrimination in Smokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session 1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline. Hypothesis: The threshold for discrimination will be 0.05 mg nicotine/pulse and the doses below that (0.025, and 0.0125 mg nicotine/pulse) will be subthreshold. Exploratory Aim: To explore the relationship between the threshold for subjective drug effects and drug discrimination.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine	Determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
DRUG	Saline	Saline will be use to determine if smokers can discriminate from the nicotine/pulse of nicotine and saline

Timeline

• Start date: 2022-02-16
• Primary completion: 2023-07-19
• Completion: 2023-08-01
• First posted: 2021-12-16
• Last updated: 2023-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study