Recruiting

Nicotine Pouches

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06043362

Conditions

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Interventions

0 mg nicotine pouch

3 mg nicotine pouch

6 mg nicotine pouch

Smooth nicotine pouch

Wintergreen nicotine pouch

Study Details

Brief 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

Tobacco Dependence

Study ID

NCT06043362

Start date

Sep 17, 2024

Status verified date

Sep, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months
  • Exhaled CO measurement of ≥ 6 parts per million at baseline
  • Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches
  • Able to understand, read and write in English
  • Access to e-mail and a smartphone/computer that has reliable internet connection
  • Able to understand and give informed consent

Exclusion Criteria:

  • Plans to quit smoking within the next 30 days
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months
  • Recent (past 3 months) unstable illness that may increase risks of participation or ability to participate fully (e.g. hospitalization for a mental health condition or substance use disorder in prior 6 months, stroke or myocardial infarction in the past year)
  • Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease \[COPD\], requiring oxygen or oral prednisone), kidney disease (e.g. requiring dialysis), liver disease (e.g cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data
  • Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days
  • Use of illegal drugs daily or weekly in the past 3 months
  • Use of combustible (smoked) recreational or medical marijuana weekly in the past 3 months (less frequent smoked medical marijuana or use of other forms of medical marijuana are ok)
  • Other member of the household currently participating in the study
  • Any other condition that in the opinion of the investigator would make it unlikely that the participant could comply with the study protocol

Study Design

Enrollment

375 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 0 mg + Smooth flavor

Participants are provided with zero strength (0 mg) nicotine pouches with smooth flavor.

experimental: 3 mg + Smooth flavor

Participants are provided with medium strength (3 mg) nicotine pouches with smooth flavor.

experimental: 6 mg + Smooth flavor

Participants are provided with high strength (6 mg) nicotine pouches with smooth flavor.

experimental: 0 mg + Wintergreen flavor

Participants are provided with zero strength (0 mg) nicotine pouches with wintergreen flavor.

experimental: 3 mg + Wintergreen flavor

Participants are provided with medium strength (3 mg) nicotine pouches with wintergreen flavor.

experimental: 6 mg + Wintergreen flavor

Participants are provided with high strength (6 mg) nicotine pouches with wintergreen flavor.

Interventions

0 mg nicotine pouch

Oral nicotine pouches that contain 0 mg of nicotine

3 mg nicotine pouch

Oral nicotine pouches that contain 3 mg of nicotine

6 mg nicotine pouch

Oral nicotine pouches that contain 6 mg of nicotine

Smooth nicotine pouch

Non-flavored nicotine pouches that are characterized as smooth.

Wintergreen nicotine pouch

Menthol flavored nicotine pouches that are characterized as wintergreen.

Primary outcome measure

  • Concentration of urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Nicolle M Krebs, MS

717-531-5673nkrebs@pennstatehealth.psu.edu

Jonathan Foulds, PhD

717-531-3504jfoulds@pennstatehealth.psu.edu

Locations

Penn State College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Nicolle M Krebs, MS

717-531-5673nkrebs@pennstatehealth.psu.edu

Principal Investigator:

Jonathan Foulds, PhD

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jason Robinson, PhD

713-745-3581jdrobinson@mdanderson.org

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-10-01.