Comparing different forms of nicotine in vaping
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
This study is testing how different types of nicotine in vaping affect experienced users' cravings, withdrawal symptoms, and enjoyment while also looking at how their bodies process these forms of nicotine.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05962229 on ClinicalTrials.gov |
What this trial studies
This study involves experienced electronic cigarette users who will vape three different forms of nicotine: natural, synthetic, and a 50:50 mixture of both. It aims to compare how these forms of nicotine are metabolized in the body, their cardiovascular effects, and how they influence users' cravings, withdrawal symptoms, and enjoyment. Participants will undergo a crossover design, allowing them to experience each form of nicotine in a controlled setting. The findings could provide insights into the pharmacokinetics and pharmacodynamics of nicotine in vaping.
Who should consider this trial
Good fit: Ideal candidates are healthy adults who are regular users of e-cigarettes for at least 15 days in the past month.
Not a fit: Patients who are pregnant, breastfeeding, or using certain medications that affect nicotine metabolism will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help inform better nicotine delivery methods and improve strategies for managing nicotine dependence.
How similar studies have performed: Other studies have explored nicotine pharmacokinetics, but this specific comparison of synthetic versus natural nicotine in vaping is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital (ZSFG) — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Neal Benowitz, MD — University of California, San Francisco
- Study coordinator: Lisa Lawrence
- Email: lisa.lawrence@ucsf.edu
- Phone: 628-206-4204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.