COMPLETED

Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures

Conditions

Electronic Cigarette Use Nicotine reduction

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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

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-use is alarming. The epidemic of ENDS use among young people in the US has been associated with the rise in popularity of ENDS products that are very efficient in delivering high doses of nicotine to users. Therefore, the investigators propose to study the effects of nicotine reduction (NR) on young ENDS users as a potential regulatory strategy to reduce the addictiveness and use of ENDS. The proposed studies are directly responsive to research priories identified by the FDA and specified in this RFA under Addiction; studying the "Impact of changes in tobacco product characteristics (e.g. nicotine formulation) on dependence". This project aims to provide an overview of this project's rationale significance divided into 1) scientific rationale and regulatory implications; 2) the need to respond to the rising trend of ENDS use among young people in the US; 3) the importance of reducing the addictiveness of ENDS; 4) the strength of our clinical and analytical lab approach for regulatory purposes; and 5) the strengths and weaknesses in the rigor of prior research about NR for ENDS.

Official Title

Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures

Quick Facts

Study Start:2022-04-01

Study Completion:2025-04-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05205382

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 Criteria	Exclusion Criteria
* 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	* 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.

Inclusion Criteria

Exclusion Criteria

* 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

* 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.

Contacts and Locations

Principal Investigator

Wasim Maziak, PhD, MD

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, PhD, MD, 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 Date2022-04-01

Study Completion Date2025-04-15

Study Record Updates

Study Start Date2022-04-01

Study Completion Date2025-04-15

Terms related to this study

Keywords Provided by Researchers

Nicotine reduction

Additional Relevant MeSH Terms

Electronic Cigarette Use