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Abuse Liability and Appeal of Oral Nicotine Products

University of Southern California · with National Cancer Institute (NCI), Food and Drug Administration (FDA) · NCT06506162

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–25 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
320
US sites recruiting
2
Study start
February 9, 2024
Record last updated
July 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Flavor; Nicotine concentration

Conditions: Nicotine Dependence

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • University of Southern California

    Los Angeles, CA 90089

    Site contact: John R Monterosso · 13107099322 · johnrmon@usc.edu

  • University of Southern California

    Los Angeles, CA 90089

    Site contact: John R Monterosso, PhD · 3107099322 · johnrmon@usc.edu

Study contacts (from the official record)

  • John R Monterosso, PhD · 3107099322 · johnrmon@usc.edu
Abuse Liability and Appeal of Oral Nicotine Products (NCT06506162) | Bored Studies