Status:

RECRUITING

Effect of Menthol on ENDS Users' Addiction and Exposure

Lead Sponsor:

Florida International University

Conditions:

Electronic Cigarette Use

Eligibility:

All Genders

21-35 years

Phase:

NA

Brief Summary

The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS heat and vaporize a nicotine-containing liquid to pr...

Detailed Description

The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the US. While estimates vary, ENDS have become the leading tobacco product used b...

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.
  • E-cigarette users (defined as using e-cigarette either daily or occasionally in the past 30 days)
  • Have abstained from e-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., e-cig, 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 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 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 :

June 22 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2027

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT05338801

Start Date

June 22 2022

End Date

March 31 2027

Last Update

March 12 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Florida International University

Miami, Florida, United States, 33199