Abuse Liability and Appeal of Oral Nicotine Products (NCT06506162)
The Effect of Flavor and Nicotine Strength on the Abuse Liability and Appeal of Oral Nicotine Products
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Southern California โ Los Angeles, California
Age range: 21 Years to 25 Years
๐งช Interventions in This Study
- Flavor (OTHER)
- Nicotine concentration (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- University of Southern California โ Los Angeles, California
- University of Southern California โ Los Angeles, California
๐ Contact the Study Coordinator
Phone: (310) 709-9322
Email: johnrmon@usc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- NeuroControl of Nicotine Dependence โ Columbia, Missouri
- Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use โ Los Angeles, California
- Orexin s Role in the Neurobiology of Substance Use Disorder โ Baltimore, Maryland
Explore by condition: All Nicotine Dependence clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.