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Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

ConditionsNicotine DependenceNicotine Vaping
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy on the basis of medical history and limited physical examination.

Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)

Disqualifiers

• 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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • (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.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: S-nicotine (tobacco) as the starting conditionExperimental treatment 3 interventions
Group B: R-nicotine (synthetic) as the starting conditionExperimental treatment 3 interventions
Group C: Racemic (50:50 S- and R- nicotine) as the starting conditionExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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