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

NCT05176418 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: HIC 2000032210
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Drug Effects Questionnaire mean score

  The DEQ measures Good Drug Effect and consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects.

  up to five years

Study Arms (2)

delivery rate for nicotine dose 1mg/70kg

ACTIVE COMPARATOR

delivery rate 50,35, 16.6 and 12.5 ug per second

Drug: low dose Nicotine

Delivery rate for nicotine dose 0.2mg/70kg

ACTIVE COMPARATOR

delivery rate 10,5, 3.3 and 2.5

Drug: high dose Nicotine

Interventions

low dose Nicotine DRUG

IV nicotine infused over different delivery rates

Also known as: IV nicotine 1mg/70kg

delivery rate for nicotine dose 1mg/70kg

high dose Nicotine DRUG

IV Nicotine infused over different delivery rates

Also known as: IV Nicotine 0.2/70kg

Delivery rate for nicotine dose 0.2mg/70kg

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mehmet Sofuoglu, M.D.,Ph.D

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

203-932-5711; mehmet.sofuoglu@yale.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: This will be a double-blind, placebo-controlled study employing a mixed design: nicotine dose as the between-subject and delivery rate as the within-subject factors.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 4, 2022
• Study Start: September 9, 2022
• Primary Completion: January 30, 2026
• Study Completion: February 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)