Effects of reducing nicotine in electronic cigarettes on addiction and health
Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures
This study tests whether lowering the nicotine levels in e-cigarettes can help young users feel less addicted and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 35 Years |
| Sex | All |
| Sponsor | Florida International University Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05205382 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of nicotine reduction on young users of electronic nicotine delivery systems (ENDS) to assess its potential as a regulatory strategy. The research focuses on comparing the effects of different nicotine levels (5%, 3%, and 0%) on dependence, satisfaction, and health metrics among current ENDS users. By utilizing clinical and analytical methods, the study aims to provide evidence on how nicotine reduction can influence addiction and exposure to harmful substances. The findings could inform regulatory decisions regarding ENDS products.
Who should consider this trial
Good fit: Ideal candidates for this study are generally healthy individuals aged 21-35 who are current users of electronic cigarettes.
Not a fit: Patients who smoke cigarettes regularly or use other tobacco products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to strategies that reduce nicotine addiction and health risks associated with electronic cigarette use among young people.
How similar studies have performed: While nicotine reduction strategies have been explored in other contexts, this specific approach targeting ENDS users is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida and 1 other locations
- Florida International University — Miami, Florida, United States (Recruiting)
- Florida International University — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Wasim Maziak, PhD, MD — Florida International University
- Study coordinator: Wasim Maziak, PhD, MD
- Email: wmaziak@fiu.edu
- Phone: 3053484501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.