This study is not yet accepting patients

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

a study on Nicotine Vaping Tobacco

Summary

Eligibility
for people ages 21-65 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Neal Benowitz, MD (ucsf)
Headshot of Neal Benowitz
Neal Benowitz

Description

Summary

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.

Keywords

Nicotine Dependence, Nicotine Vaping, Nicotine Pharmacokinetics, Nicotine Pharmacodynamics, Vaping, E-cigarettes, Tobacco Use Disorder, Nicotine, (S)-Nicotine, (R)- nicotine, Racemic nicotine

Eligibility

You can join if…

Open to people ages 21-65

  • Healthy on the basis of medical history and limited physical examination.
  • Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)

You CAN'T join if...

  • • Medications
    • Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
    • Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
    • Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).

    • Any stimulant medications (example: Adderall) generally given for ADHD treatment.

      • Pregnancy

    • Pregnancy (self-reported and urine pregnancy test)
    • Breastfeeding (determined by self-report)
    • Women of childbearing potential must be using an acceptable method of contraception
      • Inability to read and write in English
      • A known propylene glycol/vegetable glycerin allergy
      • Uncomfortable with getting blood drawn

Location

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

Lead Scientist at University of California Health

  • Neal Benowitz, MD (ucsf)
    Neal Benowitz has been involved in patient care and conducting research at SFGH since 1973. His research focus is on the human pharmacology of nicotine in relation to pathogenesis of and individual differences in vulnerability to tobacco-related disease, and the use of pharmacologic data as a basis for public health policies to prevent and reduce such disease.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05962229
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 18 study participants
Last Updated