RECRUITING

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

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

In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.

Official Title

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Quick Facts

Study Start:2024-12-06
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05962229

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy on the basis of medical history and limited physical examination.
  2. * Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)
  1. * • Medications
  2. * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
  3. * Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
  4. * Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
  5. * Any stimulant medications (example: Adderall) generally given for ADHD treatment.
  6. * Pregnancy (self-reported and urine pregnancy test)
  7. * Breastfeeding (determined by self-report)
  8. * Women of childbearing potential must be using an acceptable method of contraception
  9. * Inability to read and write in English
  10. * A known propylene glycol/vegetable glycerin allergy
  11. * Uncomfortable with getting blood drawn

Contacts and Locations

Study Contact

Lisa Lawrence
CONTACT
628-206-4204
lisa.lawrence@ucsf.edu
Armando Barraza
CONTACT
510-560-4842
armando.barraza@ucsf.edu

Principal Investigator

Neal Benowitz, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, 94110
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Neal Benowitz, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Date2024-12-06
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-12-06
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Nicotine Pharmacokinetics
  • Nicotine Pharmacodynamics
  • Vaping
  • E-cigarettes

Additional Relevant MeSH Terms

  • Nicotine Dependence
  • Nicotine Vaping