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NCT06597435 · ClinicalTrials.gov registry record · NA
Effects of Nicotine Pouch Characteristics on Perceptions and Behavior
A NA study of Nicotine Pouch Self-Administration, sponsored by University of Southern California.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT06597435: Recruiting NA study of Nicotine Pouch Self-Administration, sponsored by University of Southern California.
NCT06597435 is a NA study of Nicotine Pouch Self-Administration that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597435, a NA study of Nicotine Pouch Self-Administration, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
Study Summary
There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. Th
Primary Outcome
Self-report measures of product appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., sweetness, smoothness, bitterness, harshness) will be completed following the nicotine pouch administration.
Conditions Studied
Interventions
- OTHER Nicotine pouch
Study Locations (2)
California
- University of Southern California - Los Angeles
- University of Southern California - Clinical Sciences Building - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-10-31 |
| Est. Completion | 2025-07-31 |
| Phase | NA |
What NCT06597435 shows while recruiting
NCT06597435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Nicotine Pouch Self-Administration appearing as the primary indexed condition, and to 1 intervention - of which Nicotine pouch is the first listed.
NCT06597435 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06597435 about?
NCT06597435 is a clinical study titled "Effects of Nicotine Pouch Characteristics on Perceptions and Behavior". There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on t...
What is the current status of trial NCT06597435?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2024-10-31. Estimated completion is 2025-07-31.
What conditions does trial NCT06597435 study?
This clinical trial studies the following conditions: Nicotine Pouch Self-Administration.
What interventions are being tested in trial NCT06597435?
The interventions under investigation include: Nicotine pouch (OTHER).
Who is sponsoring clinical trial NCT06597435?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06597435 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06597435's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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