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Recruiting EARLY_Phase 1 NCT05176418

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

Trial Parameters

Condition Nicotine Dependence
Sponsor Yale University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 70
Sex ALL
Min Age 21 Years
Max Age 55 Years
Start Date 2022-09-09
Completion 2026-01-30
Interventions
low dose Nicotinehigh dose Nicotine

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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 dependenc

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