Nicotine Dependence, Nicotine Vaping
Conditions
Keywords
Nicotine Pharmacokinetics, Nicotine Pharmacodynamics, Vaping, E-cigarettes
Brief 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.
Interventions
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.
DRUGRacemic 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.
Sponsors
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
Within-subject, single-blinded crossover study. Participants will be randomized to the order of the 3 conditions using a Latin Square design.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Nicotine Exposure Over Time | Up to 7 hours | Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Amount of Nicotine Consumed Over Time | 120 minutes | Nicotine self-administration determined by device weight change before and after use multiplied by the nicotine concentration in the e-liquid |
Countries
United States
Contacts
CONTACTLisa Lawrence
CONTACTArmando Barraza
PRINCIPAL_INVESTIGATORNeal Benowitz, MD
University of California, San Francisco
Outcome results
None listed