Abuse Liability and Appeal of Oral Nicotine Products

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06506162
Status
Recruiting
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Conditions

  • Nicotine Dependence

Eligibility Criteria

Sex
ALL
Age
21 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Flavor — OTHER
    The study will compare sweet vs. cool flavors
  • Nicotine concentration — OTHER
    The study will compare low vs. high strength Oral Nicotine Products

Study Details

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.

Key Dates

Start date
Feb 9, 2024
Status verified
Jul 2024
Primary completion
Feb 14, 2028
Completion
Feb 14, 2028

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Low Nicotine Gum
    Participants in this arm will only use Lucy brand 2mg nicotine gum
  • Active Comparator: High Nicotine Gum
    Participants in this arm will only use Lucy brand 6mg nicotine gum
  • Active Comparator: Low Nicotine Pouch
    Participants in this arm will only use ON! brand 2mg nicotine pouches
  • Active Comparator: High Nicotine Pouch
    Participants in this arm will only use ON! brand 6mg nicotine pouches

Primary Outcome Measure

Product appeal ratings [ Time Frame: immediately after the intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90089
John R Monterosso
[email protected]
310-709-9322
University of Southern CaliforniaLos AngelesCalifornia90089
John R Monterosso, PhD
[email protected]
310-709-9322

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