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

NCT05205382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-09-23

No results posted yet for this study

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-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.

Conditions

  • Electronic Cigarette Use

Interventions

OTHER

5% nicotine

Effects of e-cigarette pods (JUUL/NJOY/SREC) with 5% nicotine concentration nicotine concentration

OTHER

3% nicotine

Effects of e-cigarette pods (JUUL/NJOY) with 3% nicotine concentration

OTHER

0% nicotine

Effects of e-cigarette pods (SREC) with 0% nicotine concentration

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Principal Investigators

  • Wasim Maziak, PhD, MD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205382 on ClinicalTrials.gov