NCT06506162 Abuse Liability and Appeal of Oral Nicotine Products
| NCT ID | NCT06506162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern California |
| Condition | Nicotine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2024-02-09 |
| Primary Completion | 2028-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2024-02-09 with a primary completion date of 2028-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 regulatory barriers with regard to flavoring or nicotine dose, and manufacturers have capitalized on this by introducing an extensive slate of characterizing flavors and nicotine concentrations. Both sales trajectory and the surge in marketing suggest ONP use is likely to increase in the coming years. Work by the investigators and others indicates that interest in these products is high among current EC users, and among specific demographic groups including those who identify as sexual and gender minority (SGM). ONP use is discrete and so can function as a secondary source of nicotine, encouraging dual use patterns and more severe nicotine dependence. Depending on the use patterns of ONPs that emerge, regulation of ONPs may serve the public health interest. However, very little is known about factors relevant to the actual appeal and abuse liability of these products. The investigators propose to address this important gap by assessing the appeal and abuse liability of gum and pouch ONPs as a function of flavor (mint vs fruit) and nicotine concentration (2mg vs. 4mg). Flavor and nicotine strength, along with product type, are regulatable attributes, and so it is essential to understand their impact on appeal and abuse liability. Evidence from EC use suggests a potential interaction between flavor and nicotine strength, with flavorants in the "mint" category desensitizing receptors integral to the aversive sensory experience of nicotine, leading to greater tolerability of high nicotine concentration. Because of current ONP marketing emphasis on youth, the investigators will recruit young adult exclusive EC users (N = 320; ages 21 - 25). The investigators will target recruitment of a sufficient number of SGM participants (N = 64, 20% of sample) to allow assessment of potential differentiation of this group. Participants will complete one virtual session focused on assessment of the sensory appeal of ONPs. Based on individual participant ratings, the preferred fruit and the preferred mint ONP will be selected (from their randomized product type and nicotine strength) to each be assessed in a single-product session examining factors known to predict abuse liability (relief of withdrawal, liking, behavioral economic indices of demand, and follow-up naturalistic product use). The investigators will pay particular attention to evidence suggesting dual use potential of ONPs, given its association with greater severity of nicotine dependence. The proposed work will inform efforts to mitigate ONPs potential to promote dual-use and more severe nicotine dependence among young adult EC users, by isolating the impact of potential regulatory targets.
Eligibility 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.
Contact & Investigator
John R Monterosso, PhD
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT06506162 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 25 Years, studying Nicotine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506162 currently recruiting?
Yes, NCT06506162 is actively recruiting participants. Contact the research team at johnrmon@usc.edu for enrollment information.
Where is the NCT06506162 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States.
Who is sponsoring the NCT06506162 clinical trial?
NCT06506162 is sponsored by University of Southern California. The principal investigator is John R Monterosso, PhD at University of Southern California. The trial plans to enroll 320 participants.