Abuse Liability and Appeal of Oral Nicotine Products
NCT Number: NCT06506162
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nicotine Dependence
Interventions: OTHER: Flavor|OTHER: Nicotine concentration
Sponsor: University of Southern California
Collaborators: National Cancer Institute (NCI)|Food and Drug Administration (FDA)
Sex: ALL
Age: ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-02-09
Completion Date: 2028-02-14
Locations: University of Southern California, Los Angeles, California, 90089, United States|University of Southern California, Los Angeles, California, 90089, United States

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.

Primary Outcome Measures: Product appeal ratings, Participants will rate the sensory appeal of products and their motivation to use the products, immediately after the intervention|Product consumption, Participants will have periods in which ad lib use of the product ("use as much or as little as you like") and the total used will be recorded, immediately after the intervention
Secondary Outcome Measures: Behavioral economic measures related to abuse liability, Participants will complete a purchase task that is directed at assessing valuation in the context in which alternative sources of nicotine are present, as well as when alternative sources are not present, immediately after the intervention|ad lib use at home, participants will also receive 30 ONPs that they are free to consume during a 7 day period, with use reported each morning for the previous day, 7 days after each abuse liability session