RECRUITING

Developing and Testing Health Warning Labels on the ENDS Device

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Conditions

Electronic Cigarette UseHealth Warning Labels

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this project, after systematically developing electronic nicotine delivery systems (ENDS) pictorial health warning labels (HWLs), a proven clinical lab model will be used to examine and test their effect when these are placed on the ENDS device on a variety of subjective (e.g. satisfaction, harm perception, nicotine dependence, intention to quit) and objective outcomes (e.g. plasma nicotine, puff topography) in young adults.

Official Title

Developing and Testing Health Warning Labels on the ENDS Device

Quick Facts

Study Start:2023-12-13
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04907136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Generally healthy individuals (determined by physical examination).
  2. * Age of 21-35 years.
  3. * Is willing to provide informed consent.
  4. * Is willing to attend the lab as required by the study protocol.
  5. * ENDS users (defined as using ENDS either daily or occasionally in the past 30 days)
  6. * Have abstained from ENDS use for 12 hours prior to each session.
  1. * Report smoking cigarettes regularly (\> 5 cigarettes/month in the past year).
  2. * Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
  3. * Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
  4. * Individuals with self-reported history of chronic disease or psychiatric conditions.
  5. * 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).
  6. * Individuals that report current THC (marijuana) smoking/vaping.
  7. * Individuals that report the use of non-commercial (i.e., street) e-cigarette liquid or products
  8. * 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)
  9. * Individuals that have or have been exposed to COVID-19 in the last 14 days.

Contacts and Locations

Study Contact

Wasim Maziak, MD, PhD
CONTACT
305-348-4501
wmaziak@fiu.edu

Principal Investigator

Wasim Maziak, MD, PhD
PRINCIPAL_INVESTIGATOR
Florida International University

Study Locations (Sites)

Florida International University
Miami, Florida, 33199
United States

Collaborators and Investigators

Sponsor: Florida International University

  • Wasim Maziak, MD, PhD, PRINCIPAL_INVESTIGATOR, Florida International University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Health Warning Labels

Additional Relevant MeSH Terms

  • Electronic Cigarette Use