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NCT06043362 · ClinicalTrials.gov registry record · NA
Use of Nicotine Pouches Among Daily Smokers
A NA study of Tobacco Dependence, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 375
- Enrollment target
- 2
- Study locations
NCT06043362: Recruiting NA study of Tobacco Dependence, sponsored by Milton S. Hershey Medical Center.
NCT06043362 is a NA study of Tobacco Dependence that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 375 participants, below the 465-participant average among 28 other Tobacco Dependence trials with a reported enrollment target (19% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06043362, a NA study of Tobacco Dependence, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 375 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this clinical trial is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. The main aims are: 1. Understand the impact of nicotine pouch use on toxicant exposure biomarkers, and indicators of potential harms to health. 2. Examine the influence of nicotine pouch use on conventional tobacco product use (cigarettes). Participants will be randomized to one of six nicotine pouch groups (3 nicotine strengths, each with 2 potential flavors) to use over 16 weeks and asked to reduce their cigarette smoking over that time by at least 75% by substituting with the use of the nicotine pouches. Researchers will compare the outcomes of the different nicotine pouch strengths and flavors to each other. Participants will be asked to complete study questionnaires and provide urine, exhaled carbon monoxide, and mouth cell samples, and other health measurements.
Primary Outcome
Measure of tobacco-specific nitrosamine
Conditions Studied
Interventions
- OTHER 0 mg nicotine pouch
- OTHER 3 mg nicotine pouch
- OTHER 6 mg nicotine pouch
- OTHER Smooth nicotine pouch
- OTHER Wintergreen nicotine pouch
Study Locations (2)
Pennsylvania
- Penn State College of Medicine - Hershey
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2028-08 |
| Phase | NA |
What NCT06043362 shows while recruiting
NCT06043362 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 465-participant average among 28 other Tobacco Dependence trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Tobacco Dependence appearing as the primary indexed condition, and to 5 interventions - of which 0 mg nicotine pouch is the first listed.
NCT06043362 reports a single indexed study location in Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT06043362 about?
NCT06043362 is a clinical study titled "Use of Nicotine Pouches Among Daily Smokers". The purpose of this clinical trial is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. The main aims are: 1. Understand the impact of nicotine pouch use on toxicant exposure biomarkers, and indicator...
What is the current status of trial NCT06043362?
This trial is currently recruiting. It is a NA study. The enrollment target is 375 participants. The study started on 2024-09-17. Estimated completion is 2028-08.
What conditions does trial NCT06043362 study?
This clinical trial studies the following conditions: Tobacco Dependence.
What interventions are being tested in trial NCT06043362?
The interventions under investigation include: 0 mg nicotine pouch (OTHER), 3 mg nicotine pouch (OTHER), 6 mg nicotine pouch (OTHER), Smooth nicotine pouch (OTHER), Wintergreen nicotine pouch (OTHER).
Who is sponsoring clinical trial NCT06043362?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06043362 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06043362's enrollment target sits among peer trials
375 11th of 28 higher than 18 of 28 other Tobacco Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Dependence 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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