Status:
COMPLETED
Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures
Lead Sponsor:
Florida International University
Conditions:
Electronic Cigarette Use
Eligibility:
All Genders
21-35 years
Phase:
NA
Brief Summary
The rapid increase of electronic nicotine delivery systems (ENDS) use by young people in the US and their potential to harm health, cause addiction, and serve as a risk for cigarette smoking or dual-u...
Detailed Description
The use of electronic nicotine delivery systems (ENDS or e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS emit toxic substances, including nicotine that irr...
Eligibility Criteria
Inclusion
- Generally healthy individuals (determined by physical examination).
- Age of 21-35 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- Electronic cigarette users (defined as using electronic cigarette either daily or occasionally in the past 30 days)
- Have abstained from electronic cigarette use for 12 hours prior to each session
Exclusion
- Report smoking cigarettes regularly (\> 5 cigarettes/month in the past year).
- Report regular use of any other tobacco/nicotine product (e.g.,hookah, pipes, cigars) in the past year.
- Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
- Individuals with self-reported history of chronic disease or current psychiatric conditions.
- Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
- Individuals that report current THC (marijuana) smoking/vaping.
- Individuals that report the use of non-commercial (i.e., street) e-cigarette liquid or products
- Individuals that report current EVALI or COVID-19 related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss)
- Individuals that have or have been exposed to COVID-19 in the last 14 days.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05205382
Start Date
April 1 2022
End Date
April 15 2025
Last Update
September 23 2025
Active Locations (1)
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1
Florida International University
Miami, Florida, United States, 33199