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NCT Number: NCT05962229

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Mental Disorders Nicotine Vaping Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(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.

Other names: 50:50 mixture of (S)- and (R)-nicotine

Primary outcomes

  1. Mean Nicotine Exposure Over Time

    Time frame: Up to 7 hours

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

Secondary outcomes

  1. Mean Amount of Nicotine Consumed Over Time

    Time frame: 120 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Armando Barraza

CONTACT

[email protected]

510-560-4842

Lisa Lawrence

CONTACT

[email protected]

628-206-4204

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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