Exploring the appeal and risks of oral nicotine products among young adult e-cigarette users
The Effect of Flavor and Nicotine Strength on the Abuse Liability and Appeal of Oral Nicotine Products
This study looks at how appealing and risky new oral nicotine products are for young adults who only use e-cigarettes to see how flavors and nicotine levels affect their choices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 21 Years to 25 Years |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06506162 on ClinicalTrials.gov |
What this trial studies
This study investigates the appeal and potential abuse liability of novel oral nicotine products (ONPs) among young adults who are current exclusive e-cigarette users. It focuses on understanding how factors such as flavor and nicotine concentration influence the use patterns of ONPs, particularly in the context of increasing regulatory restrictions on e-cigarettes. By examining these dynamics, the research aims to inform public health regulations that could mitigate the risks associated with dual use of e-cigarettes and ONPs. Participants will be young adults aged 21-25 who have been using e-cigarettes regularly and have never tried ONPs.
Who should consider this trial
Good fit: Ideal candidates for this study are young adults aged 21-25 who are current exclusive e-cigarette users and have never used any oral nicotine products.
Not a fit: Patients who are not exclusive e-cigarette users or those who have used oral nicotine products in the past will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better regulations that protect young adults from increased nicotine dependence due to dual use of e-cigarettes and oral nicotine products.
How similar studies have performed: While there is limited research specifically on oral nicotine products, studies on e-cigarettes and their appeal among young adults have shown significant findings, suggesting that this area of investigation is both relevant and timely.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged 21-25 years 2. current exclusive EC user (defined as at least weekly use over the past 3 months) and recent nicotine use confirmed by positive urine test (\>1 semiquantitative Total Nicotine Equivalent; see below) 3. not currently using another tobacco/nicotine product (defined as no use in the past 6 months) 4. have never used any ONP (medicinal or nonmedicinal) 5. willing to try study provided ONPs. Exclusion Criteria: 1. recent COVID-19+ (positive test in the past 30 days) 2. a recent COVID-19 hospitalization (past 3 months) 3. unstable or significant psychiatric conditions (past and stable conditions allowed) 4. history of cardiac event or distress within the past 3 months 5. currently pregnant (based on urine pregnancy test), planning to become pregnant, or breastfeeding.
Where this trial is running
Los Angeles, California and 1 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: John R Monterosso, PhD — University of Southern California
- Study coordinator: John R Monterosso, PhD
- Email: johnrmon@usc.edu
- Phone: 3107099322
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.