Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, San Francisco
About this trial
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
Qualifiers
Healthy on the basis of medical history and limited physical examination.
Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)
Disqualifiers
• 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).
Trial design
Treatments tested in this trial
- (S)-Nicotine
- (R)- nicotine
- Racemic nicotine
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov