RECRUITING

Abuse Liability and Appeal of Oral Nicotine Products

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Flavor and Nicotine Strength on the Abuse Liability and Appeal of Oral Nicotine Products

Quick Facts

Study Start:2024-02-09
Study Completion:2028-02-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06506162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. aged 21-25 years
  2. 2. 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)
  3. 3. not currently using another tobacco/nicotine product (defined as no use in the past 6 months)
  4. 4. have never used any ONP (medicinal or nonmedicinal)
  5. 5. willing to try study provided ONPs.
  1. 1. recent COVID-19+ (positive test in the past 30 days)
  2. 2. a recent COVID-19 hospitalization (past 3 months)
  3. 3. unstable or significant psychiatric conditions (past and stable conditions allowed)
  4. 4. history of cardiac event or distress within the past 3 months
  5. 5. currently pregnant (based on urine pregnancy test), planning to become pregnant, or breastfeeding.

Contacts and Locations

Study Contact

John R Monterosso, PhD
CONTACT
3107099322
johnrmon@usc.edu

Principal Investigator

John R Monterosso, PhD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90089
United States
University of Southern California
Los Angeles, California, 90089
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • John R Monterosso, PhD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-09
Study Completion Date2028-02-14

Study Record Updates

Study Start Date2024-02-09
Study Completion Date2028-02-14

Terms related to this study

Additional Relevant MeSH Terms

  • Nicotine Dependence