NCT05658471

Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)

Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.

Detailed description

OBJECTIVES: I. To characterize nicotine delivery, systemic exposure and effects from SREC in comparison with usual to usual nicotine brand use. II. To assess aspects of harm of SREC use compared to usual nicotine brand use. OUTLINE: Eligible participants will be assigned to one of two treatment conditions for the initial assessment which will take place in a hospital setting. The participant will then be assigned to the second condition within 2 weeks after the initial assessment which will also take place in a hospital setting to repeat the same procedures.

Conditions

• Nicotine Dependence
• Tobacco Toxicity
• Cardiovascular Risk Factors

Interventions

Type	Name	Description
OTHER	Standardized Research E-Cigarette (SREC)	Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.
OTHER	Over the Counter E-Cigarette (EC)	Usual brand e-cigarettes will be provided at the hospital stay.
BEHAVIORAL	Biological Samples	Blood, urine, and expired carbon dioxide will be obtained during the course of the study.
OTHER	Smoking-related Questionnaires	Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2022-12-20
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States