CompletedNot Applicable

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

United States116 participantsStarted 2022-04-01

Plain-language 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.

Who can participate

Age range21 Years – 35 Years

SexALL

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Inclusion 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 Exclusion Criteria: * 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.

What they're measuring

Plasma nicotine

Timeframe: During the 2 participant visits. Blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period

Trial details

NCT IDNCT05205382

SponsorFlorida International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-15