Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Phase 1RecruitingNCT05962229

University of California, San Francisco18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Nicotine Dependence Nicotine Vaping

Interventions

(S)-NicotineDRUG

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)- nicotineDRUG

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 nicotineDRUG

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

Lisa Lawrence

CONTACT

628-206-4204 lisa.lawrence@ucsf.edu

Armando Barraza

CONTACT

510-560-4842 armando.barraza@ucsf.edu

Data from ClinicalTrials.gov

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