RECRUITINGPhase 1INTERVENTIONAL

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Healthy on the basis of medical history and limited physical examination. - Current regular user of E-Cigarettes (≥ 15 days in the past 30 days) Who Should NOT Join This Trial: - • 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

(S)-Nicotine

Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.

DRUG

(R)- nicotine

Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (R)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.

DRUG

Racemic nicotine

Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 50% (R)-nicotine and 50% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.

Locations (1)

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, United States