Actively Recruiting
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine in Experienced E-Cigarette Users
Led by University of California, San Francisco · Updated on 2026-05-14
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing how the body processes and responds to three types of nicotine used in e-cigarettes: natural nicotine derived from tobacco, synthetic nicotine, and a 50:50 mix of both. This phase 1 study focuses on experienced e-cigarette users to understand differences in nicotine metabolism, heart effects, use patterns, cravings, withdrawal, and enjoyment. Participants will stay in a hospital research ward for 8 hours on three separate occasions, each time vaping e-liquid containing either 100% natural nicotine, 100% synthetic nicotine, or a 50:50 mixture. Each session includes a standardized vaping period, followed by 4 hours without vaping, then 90 minutes of vaping as they wish. This crossover design allows comparison of the three nicotine types in the same individuals. During the study, researchers will measure nicotine exposure over up to 7 hours, amount of nicotine consumed, cardiovascular effects, and participants' feelings related to cravings and enjoyment. Participants will undergo medical history review, physical exams, and blood draws. The total participation includes multiple visits and monitoring in a controlled setting to assess the pharmacokinetics and pharmacodynamics of the different nicotine forms.
CONDITIONS
Brief Title
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy based on medical history and limited physical exam
- Current regular user of e-cigarettes, vaping at least 15 days in the past 30 days
- Age between 21 and 65 years
- Willingness to participate in all study visits and procedures
You will not qualify if you...
- Use of medications that induce nicotine metabolizing enzyme CYP2A6 (e.g., rifampicin, carbamazepine, phenobarbital)
- Use of sympatholytic medications for cardiovascular conditions, including beta and alpha-blockers
- Concurrent use of nicotine-containing medications such as patches, lozenges, or gum
- Use of stimulant medications typically for ADHD treatment, such as Adderall
- Pregnancy or breastfeeding
- Women of childbearing potential not using acceptable contraception
- Inability to read and write in English
- Known allergy to propylene glycol or vegetable glycerin
- Discomfort with blood draws during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 hours per session
Participants vape e-liquid containing different types of nicotine during sessions in the hospital research ward, including a standardized vaping session, a 4-hour abstinence period, and an ad libitum vaping period.
1 to 3 inpatient visits depending on nicotine type sequence
Trial Site Locations
Total: 1 location
1
Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
L
Lisa Lawrence
A
Armando Barraza
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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