Nicotine Differences in Smokers

Phase 1

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Saline; Drug: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine

• Registration Number: NCT05159934
• Lead Sponsor: Yale University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-16
• Study Start: 2022-02-16
• Primary Completion: 2023-07-19
• Study Completion: 2023-08-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine	Saline	Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
saline	0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine	Saline will compared to different nicotine doses. Nicotine doses: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Primary Outcome Measures

Name	Time	Method
Drug Effect Questionnaire	over 3 hours	Liking effect

Trial Locations

Locations (1)

Veterans Affairs Hospital; 🇺🇸 West Haven, Connecticut, United States