RECRUITING

IV Pulsed-Nicotine As a Model of Smoking: the Effects of Dose and Delivery Rate

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Conditions

Nicotine Dependence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IV Pulsed-Nicotine As a Model of Smoking: the Effects of Dose and Delivery Rate

Quick Facts

Study Start:2022-09-09
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05176418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female and male, aged 21 to 55 years;
  2. * 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
  3. * women, -using acceptable birth control methods.
  1. * History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study
  2. * 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
  3. * regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
  4. * current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
  5. * for women, pregnant as determined by pregnancy screening, or breast feeding
  6. * seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.

Contacts and Locations

Study Contact

Mehmet Sofuoglu,, M.D.,Ph.D.
CONTACT
203-932-5711
mehmet.sofuoglu@yale.edu

Principal Investigator

Mehmet Sofuoglu, M.D.,Ph.D
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

VA Healthcare System
West Haven, Connecticut, 06516
United States

Collaborators and Investigators

Sponsor: Yale University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-09
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2022-09-09
Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Nicotine Dependence