ClinicalTrials.gg
RecruitingNCT05962229Updated May 14, 2026

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

A Phase 1 interventional study of (S)-Nicotine and (R)- nicotine in Nicotine Dependence and Nicotine Vaping, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nicotine Dependence
  • Nicotine Vaping

Keywords

  • Nicotine Pharmacokinetics
  • Nicotine Pharmacodynamics
  • Vaping
  • E-cigarettes
03

In context

Tobacco Use Disorder

1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.

This study's planned enrollment of 18 is below the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 must be using an acceptable method of

        • Inability to read and write in English
        • A known propylene glycol/vegetable glycerin allergy
        • Uncomfortable with getting blood drawn
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
18 participants (estimated)

Study 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.

    Drug: (S)-Nicotine · Drug: (R)- nicotine · Drug: Racemic 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.

    Drug: (S)-Nicotine · Drug: (R)- nicotine · Drug: Racemic 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.

    Drug: (S)-Nicotine · Drug: (R)- nicotine · Drug: Racemic nicotine

Interventions

  • 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.

  • 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.

    Also known as: 50:50 mixture of (S)- and (R)-nicotine

06

What researchers measure

Primary outcomes

  1. Mean Nicotine Exposure Over Time

    Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h)

    Time frame: Up to 7 hours

Secondary outcomes

  1. Mean Amount of Nicotine Consumed Over Time

    Nicotine self-administration determined by device weight change before and after use multiplied by the nicotine concentration in the e-liquid

    Time frame: 120 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05962229
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Dec 6, 2024
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
May 14, 2026

Study contacts

Lisa Lawrence
Contact
lisa.lawrence@ucsf.edu
628-206-4204
Armando Barraza
Contact
armando.barraza@ucsf.edu
510-560-4842
Neal Benowitz, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Nicotine

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