RECRUITING

Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)

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Conditions

Nicotine DependenceTobacco ToxicityCardiovascular Risk FactorsNicotine PharmacokineticsNicotine PharmacodynamicsElectronic CigarettesE-Cigarettes

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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 is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.

Official Title

Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette

Quick Facts

Study Start:2023-02-01
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05658471

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 70 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. * Heart rate \< 105 beats per minute (BPM)\*.
  3. * Systolic Blood Pressure \< 160 and \> 90\*.
  4. * Diastolic Blood Pressure \< 100 and \> 50\*.
  5. * \*considered out of range if both machine and manual readings are above/below these thresholds.
  6. * Body Mass Index \<= 38.0.
  7. * Current regular user of electronic cigarettes (EC)
  8. * EC device use at least 15 or more days in the past 30 days (with e- liquid \>= 3mg/ml)
  9. * No restriction on flavor or type of e-cigarette used
  10. * Saliva cotinine \>= 50 ng/ml and/or NicAlert = 6
  11. * Age \>= 21 years old \<= 70 years old
  12. * Willingness to abstain from drug use for the duration of the study
  1. * The following unstable medical conditions:
  2. * Heart disease
  3. * Seizures
  4. * Cancer
  5. * Thyroid disease (okay if controlled with medication)
  6. * Diabetes
  7. * Hepatitis B or C or Liver disease
  8. * Glaucoma
  9. * Kidney disease or urinary retention
  10. * History of stroke
  11. * An ulcer in the past year
  12. * Active use of an inhaler for Asthma or chronic obstructive pulmonary disease (COPD)
  13. * Medications
  14. * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
  15. * Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
  16. * Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
  17. * Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment.
  18. * Other/Misc. Health Conditions
  19. * Oral thrush
  20. * Fainting (within the last 30 days)
  21. * Other "life threatening illnesses" as per principal investigator and/or study physician's discretion
  22. * Pregnancy
  23. * Pregnancy (self-reported and urine pregnancy test)
  24. * Breastfeeding (determined by self-report)
  25. * Women of childbearing potential must be using an acceptable method of contraception
  26. * Concurrent participation in another clinical trial.
  27. * Inability to read and write in English
  28. * Planning to quit smoking or vaping within the next 60 days
  29. * A known propylene glycol/vegetable glycerin allergy
  30. * Uncomfortable with getting blood drawn
  31. * Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks

Contacts and Locations

Study Contact

Lisa Lawrence
CONTACT
415-608-4864
Lisa.Lawerence@ucsf.edu
Angie Bustos
CONTACT
Angie.Bustos@ucsf.edu

Principal Investigator

Neal Benowitz, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco - Tobacco Research Center
San Francisco, California, 94143
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 Date2023-02-01
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Nicotine Pharmacokinetics
  • Nicotine Pharmacodynamics
  • Electronic Cigarettes
  • E-Cigarettes

Additional Relevant MeSH Terms

  • Nicotine Dependence
  • Tobacco Toxicity
  • Cardiovascular Risk Factors