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IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate

NCT05176418 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-02

No results posted yet for this study

Summary

This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.

Conditions

  • Nicotine Dependence

Interventions

DRUG

low dose Nicotine

IV nicotine infused over different delivery rates

DRUG

high dose Nicotine

IV Nicotine infused over different delivery rates

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Mehmet Sofuoglu, M.D.,Ph.D · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2026-01-30
Completion
2026-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05176418 on ClinicalTrials.gov