Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (S)-Nicotine, (R)- nicotine, Racemic nicotine.
- Who it may be relevant to
- Registry conditions: Nicotine Dependence, Nicotine Vaping. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. - 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.
Primary outcome measures
- Mean Nicotine Exposure Over Time [Time frame: Up to 7 hours]
Secondary outcome measures (1)
- Mean Amount of Nicotine Consumed Over Time [Time frame: 120 minutes]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Zuckerberg San Francisco General Hospital (ZSFG) — San Francisco
Identifiers
NCT: NCT05962229 · 22-36348 · 1R01DA057282-01