NCT05962229PHASE1RecruitingAccepts Healthy Volunteers
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
University of California, San Francisco
Start Date
12/6/2024
Completion Date
5/1/2027
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.
Eligibility Criteria
Age Range: 21 years to 65 years
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
Interventions
DRUG
(S)-Nicotine
DRUG
(R)- nicotine
DRUG
Racemic nicotine
Conditions
Nicotine DependenceNicotine Vaping
Locations
Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California 94110
United States