Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05962229
Phase
PHASE1
Status
Recruiting
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Conditions

  • Nicotine Dependence
  • Nicotine Vaping

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • (S)-Nicotine — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Mean Nicotine Exposure Over Time [ Time Frame: Up to 7 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General Hospital (ZSFG)San FranciscoCalifornia94110
Lisa Lawrence
[email protected]
415-502-2465
Armando Barraza
[email protected]
415-502-2465
Neal Benowitz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Zuckerberg San Francisco General Hospital (ZSFG)· San Francisco, CA

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