Actively Recruiting

Phase Not Applicable
Age: 21Years - 25Years
All Genders
Healthy Volunteers
NCT06506162

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

Age: 21Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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