Recruiting

Oral Nicotine Products

Sponsor:

University of Southern California

Code:

NCT06506162

Conditions

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 21 - 25

Healthy Volunteers: Accepted

Interventions

Flavor

Nicotine concentration

Study Details

Brief summary:

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

Nicotine Dependence

Study ID

NCT06506162

Start date

Feb 9, 2024

Status verified date

Jul, 2026

Completion date

Feb 14, 2028

Anticipated

Primary completion date

Feb 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

1. aged 21-25 years
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. not currently using another tobacco/nicotine product (defined as no use in the past 6 months)
4. have never used any ONP (medicinal or nonmedicinal)
5. willing to try study provided ONPs.

Exclusion Criteria:

1. recent COVID-19+ (positive test in the past 30 days)
2. a recent COVID-19 hospitalization (past 3 months)
3. unstable or significant psychiatric conditions (past and stable conditions allowed)
4. history of cardiac event or distress within the past 3 months
5. currently pregnant (based on urine pregnancy test), planning to become pregnant, or breastfeeding.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Flavor

The study will compare sweet vs. cool flavors

Nicotine concentration

The study will compare low vs. high strength Oral Nicotine Products

Primary outcome measure

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

Central Contacts and Locations

Central contacts

John R Monterosso, PhD

3107099322johnrmon@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

John R Monterosso, PhD

3107099322johnrmon@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-07-09.