NOT_YET_RECRUITING
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
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.
Conditions:
🦠 Nicotine Dependence 🦠 Nicotine Vaping
🗓️ Study Start (Actual) 1 June 2024
🗓️ Primary Completion (Estimated) September 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 18
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 17 July 2023
  • First Submitted that Met QC Criteria 17 July 2023
  • First Posted 27 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 April 2024
  • Last Update Posted 1 May 2024
  • Last Verified April 2024