Actively Recruiting

Early Phase 1
Age: 21Years - 55Years
All Genders
NCT05176418

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

Led by Yale University · Updated on 2025-09-02

70

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Female and male, aged 21 to 55 years
  • Daily cigarette use for the past year confirmed by urine cotinine levels above 100 ng/ml
  • Lifetime history of e-cigarette use
  • Good health as confirmed by medical history, screening exam, and lab tests
  • Women using acceptable birth control methods
Not Eligible

You will not qualify if you...

  • History of major medical or psychiatric disorders deemed unsafe for study participation
  • Risk factors for EVALI including history of lung diseases like asthma or COPD, or vaping THC or CBD
  • Regular use of psychotropic medications such as antidepressants, antipsychotics, or anxiolytics
  • Current alcohol or substance use disorder except nicotine
  • Pregnant or breastfeeding women
  • Seeking or undergoing treatment for tobacco dependence
  • Aversion to e-cigarettes or tobacco-flavored e-liquid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Healthcare System

West Haven, Connecticut, United States, 06516

Actively Recruiting

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Research Team

M

Mehmet Sofuoglu,, M.D.,Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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