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About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Healthy on the basis of medical history and limited physical examination-
Current regular user of electronic cigarettes (EC)
Age >= 21 years old <= 70 years old
Willingness to abstain from drug use for the duration of the study
Exclusion criteria
The following unstable medical conditions:
Medications
Other/Misc. Health Conditions
Pregnancy
Concurrent participation in another clinical trial.
Inability to read and write in English
Planning to quit smoking or vaping within the next 60 days
A known propylene glycol/vegetable glycerin allergy
Uncomfortable with getting blood drawn
Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
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Central trial contact
Lisa Lawrence
Data sourced from clinicaltrials.gov
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