Status:
RECRUITING
Abuse Liability and Appeal of Oral Nicotine Products
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
21-25 years
Phase:
NA
Brief Summary
There has been a recent proliferation of novel oral nicotine products (ONPs) brought to market, including new nicotine gums and pouches. Unlike electronic cigarettes (ECs) ONPs have no impending regul...
Detailed Description
E-cigarettes (ECs) have been the predominant flavored non-combustible tobacco product used by young adults since 2014,(Ali et al. 2022) and are disproportionately used by sexual/gender minorities (SGM...
Eligibility Criteria
Inclusion
- aged 21-25 years
- 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)
- not currently using another tobacco/nicotine product (defined as no use in the past 6 months)
- have never used any ONP (medicinal or nonmedicinal)
- willing to try study provided ONPs.
Exclusion
- recent COVID-19+ (positive test in the past 30 days)
- a recent COVID-19 hospitalization (past 3 months)
- unstable or significant psychiatric conditions (past and stable conditions allowed)
- history of cardiac event or distress within the past 3 months
- currently pregnant (based on urine pregnancy test), planning to become pregnant, or breastfeeding.
Key Trial Info
Start Date :
February 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2028
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06506162
Start Date
February 9 2024
End Date
February 14 2028
Last Update
July 17 2024
Active Locations (2)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
University of Southern California
Los Angeles, California, United States, 90089