Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

Use of Nicotine Pouches Among Daily Smokers

NCT06043362 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 375 participants
Start Date 2024-09-17
Est. Completion 2028-08
Phase NA

Sponsor

Milton S. Hershey Medical Center

277 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06043362

The ClinicalTrials.gov registry entry for NCT06043362 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 277 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06043362 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06043362?

This trial is sponsored by Milton S. Hershey Medical Center, which has 277 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial