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NCT06506162 · ClinicalTrials.gov registry record · NA
Abuse Liability and Appeal of Oral Nicotine Products
A NA study of Nicotine Dependence, sponsored by University of Southern California.
- Recruiting
- Registry status
- NA
- Development phase
- 320
- Enrollment target
- 2
- Study locations
NCT06506162 is a NA study of Nicotine Dependence that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 320 participants, above the 182-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (76% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT06506162, a NA study of Nicotine Dependence, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- NA
- Development phase
- 320 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- OTHER Flavor
- OTHER Nicotine concentration
Study Locations (2)
California
- University of Southern California - Los Angeles
- University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2024-02-09 |
| Est. Completion | 2028-02-14 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06506162
The ClinicalTrials.gov registry entry for NCT06506162 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 182-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (76% higher). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 2 interventions - of which Flavor is the first listed.
NCT06506162 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06506162 about?
NCT06506162 is a clinical study titled "Abuse Liability and Appeal of Oral Nicotine Products". 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...
What is the current status of trial NCT06506162?
This trial is currently recruiting. It is a NA study. The enrollment target is 320 participants. The study started on 2024-02-09. Estimated completion is 2028-02-14.
What conditions does trial NCT06506162 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT06506162?
The interventions under investigation include: Flavor (OTHER), Nicotine concentration (OTHER).
Who is sponsoring clinical trial NCT06506162?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06506162 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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