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Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Recruiting
21-65 years
All
Phase 1

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Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • • 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

Study details
    Nicotine Dependence
    Nicotine Vaping

NCT05962229

University of California, San Francisco

12 April 2025

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