Actively Recruiting

Phase Not Applicable
Age: 21Years - 25Years
All Genders
Healthy Volunteers
ID06506162

The Effect of Flavor and Nicotine Strength on the 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

N/A

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

Researchers are investigating the appeal and potential for abuse of new oral nicotine products (ONPs), such as gums and pouches, among young adults who currently use e-cigarettes (ECs). This study focuses on how flavor (mint vs. fruit) and nicotine strength (2mg vs. 6mg) influence the attractiveness and abuse risk of these products. Special attention is given to sexual and gender minority (SGM) individuals, as they show higher interest in ONPs. Understanding these factors will help guide regulations to prevent harmful dual use of ECs and ONPs that may increase nicotine dependence. Participants will be randomly assigned to use either nicotine gum or pouches with a low (2mg) or high (6mg) nicotine dose. The study involves three virtual sessions conducted remotely, where participants self-administer different flavored ONPs and provide ratings on appeal and sensory experiences. Following initial sensory testing, participants complete two abuse liability sessions with their preferred mint and fruit flavors, including controlled use and a seven-day period of naturalistic product use at home. Throughout the study, participants will complete surveys on nicotine withdrawal, cravings, and subjective effects. Behavioral economic measures will assess the demand for ONPs under different conditions. Researchers will monitor natural use patterns, including use in places where vaping is usually restricted. The primary outcomes are product appeal and consumption immediately after use, with additional measures taken during and after the abuse liability sessions. Participants will be closely monitored for nicotine abstinence and adherence during each phase of the study.

CONDITIONS

Brief 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 e-cigarette user with 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 (medicinal or nonmedicinal)
  • 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
  • Hospitalization due to COVID-19 in the past 3 months
  • Unstable or significant psychiatric conditions (stable conditions allowed)
  • History of cardiac event or distress within the past 3 months
  • Currently pregnant, planning to become pregnant, or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Initial phone screen and online screener; orientation session conducted over Zoom for informed consent and baseline assessments.

Orientation and Randomization

Duration - 1 day

Participants complete baseline assessments including a urine nicotine test and demographic surveys; then they are randomized to one of four groups based on oral nicotine product type and nicotine concentration.

1 online orientation session (remote, via Zoom)

ONP Appeal Session

Duration - 1 day

Participants self-administer four flavored oral nicotine products (two mint and two fruit) in a single visit to rate product appeal and sensory attributes.

1 online experimental session with controlled product use

Abuse Liability Sessions

Duration - 2 weeks

Participants complete two separate sessions testing abuse liability for their top-rated fruit and mint flavored oral nicotine products, each followed by a 7-day period of naturalistic product use and daily reporting.

2 online experimental sessions plus daily electronic surveys for 7 days after each session

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

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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Published Research Related To This Trial

Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional, Tobacco-Based Swedish Snus and American Moist Snuff.

Erik Lunell, Karl Fagerström, John Hughes...

https://pubmed.ncbi.nlm.nih.gov/32319528

Effects of non-tobacco flavors and nicotine on e-cigarette product appeal among young adult never, former, and current smokers.

Adam M Leventhal, Nicholas I Goldenson, Jessica L Barrington-Trimis...

https://pubmed.ncbi.nlm.nih.gov/31434028

Sensory attributes of e-cigarette flavours and nicotine as mediators of interproduct differences in appeal among young adults.

Adam Leventhal, Junhan Cho, Jessica Barrington-Trimis...

https://pubmed.ncbi.nlm.nih.gov/31852818

Polytobacco Use Among a Nationally Representative Sample of Adolescent and Young Adult E-Cigarette Users.

Jessica L King, David Reboussin, Jennifer Cornacchione Ross...

https://pubmed.ncbi.nlm.nih.gov/30115508