Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

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