Actively Recruiting
Abuse Liability and Appeal of Oral Nicotine Products
Led by University of Southern California · Updated on 2024-07-17
320
Participants Needed
2
Research Sites
209 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Abuse Liability and Appeal of Oral Nicotine Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 25 years
- Current exclusive electronic cigarette user (at least weekly use over the past 3 months)
- Recent nicotine use confirmed by a positive urine test
- No use of other tobacco or nicotine products in the past 6 months
- Never used any oral nicotine products before
- Willing to try study-provided oral nicotine products
You will not qualify if you...
- Positive COVID-19 test in the past 30 days
- Recent COVID-19 hospitalization in the past 3 months
- Unstable or significant psychiatric conditions (stable past conditions allowed)
- History of cardiac event or distress within the past 3 months
- Currently pregnant, planning to become pregnant, or breastfeeding
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Trial Site Locations
Total: 2 locations
1
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
Research Team
J
John R Monterosso, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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