Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
NCT ID: NCT05962229
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2024-12-06
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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S-nicotine (tobacco) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.
(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.
(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.
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.
R-nicotine (synthetic) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.
(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.
(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.
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.
Racemic (50:50 S- and R- nicotine) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.
(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.
(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.
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.
Interventions
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(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.
(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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)
Exclusion Criteria
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Neal Benowitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Lisa Lawrence
Role: primary
Armando Barraza
Role: backup
Other Identifiers
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22-36348
Identifier Type: -
Identifier Source: org_study_id