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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT05176418

Run by

Yale University

People needed

20

Starts

2022-09-09

Expected to finish

2025-10-08

Last updated by the study team

2026-06-09

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female and male, aged 21 to 55 years;
• past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests
• women, -using acceptable birth control methods.

You may not qualify if…

• History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study
• risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD
• regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
• current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
• for women, pregnant as determined by pregnancy screening, or breast feeding
• seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.

Where it is running

• VA Healthcare System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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