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

Launched by FLORIDA INTERNATIONAL UNIVERSITY · Jan 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how reducing the amount of nicotine in electronic cigarettes (also known as ENDS) affects young users' addiction and health risks. Researchers are concerned about the rising use of ENDS among young people in the U.S., as these products can lead to addiction and potentially increase the chances of starting to smoke traditional cigarettes. By testing different levels of nicotine, the study aims to find ways to make ENDS less addictive, which could help decrease their use and promote better health outcomes.

To participate in this trial, individuals must be generally healthy, aged between 21 and 35, and currently use electronic cigarettes. Participants will need to attend lab sessions and will have to refrain from using e-cigarettes for 12 hours before each visit. However, those who smoke regular cigarettes, use other tobacco products, or have certain health conditions are not eligible. Throughout the study, participants can expect to be in a supportive environment where their health and experiences with ENDS will be carefully monitored. This research is important as it seeks to address the growing trend of e-cigarette use among young people and its potential health impacts.

Gender

ALL

Eligibility criteria

• 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.