Use of Nicotine Pouches Among Daily Smokers

NCT06043362 | Recruiting DMC

• 2 other identifiers: STUDY000230561U54DA058271
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 2

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. 1.Understand the impact of nicotine pouch use on toxicant exposure biomarkers, and indicators of potential harms to health.
2. 2.Examine the influence of nicotine pouch use on conventional tobacco product use (cigarettes).

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Concentration of urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)

  Measure of tobacco-specific nitrosamine

  Week 16

Secondary Outcomes (7)

• Level of carbon monoxide in exhaled breath

  Week 16

• Concentration of urinary cotinine

  Week 16

• Penn State Cigarette Dependence Index score

  Week 16

• Penn State Nicotine Pouch Dependence Index score

  Week 16

• Mean number of cigarettes per day

  Week 16

Study Arms (6)

0 mg + Smooth flavor

EXPERIMENTAL

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

Other: 0 mg nicotine pouch; Other: Smooth nicotine pouch

3 mg + Smooth flavor

EXPERIMENTAL

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

Other: 3 mg nicotine pouch; Other: Smooth nicotine pouch

6 mg + Smooth flavor

EXPERIMENTAL

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

Other: 6 mg nicotine pouch; Other: Smooth nicotine pouch

0 mg + Wintergreen flavor

EXPERIMENTAL

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

Other: 0 mg nicotine pouch; Other: Wintergreen nicotine pouch

3 mg + Wintergreen flavor

EXPERIMENTAL

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

Other: 3 mg nicotine pouch; Other: Wintergreen nicotine pouch

6 mg + Wintergreen flavor

EXPERIMENTAL

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

Other: 6 mg nicotine pouch; Other: Wintergreen nicotine pouch

Interventions

0 mg nicotine pouch OTHER

Oral nicotine pouches that contain 0 mg of nicotine

0 mg + Smooth flavor; 0 mg + Wintergreen flavor

3 mg nicotine pouch OTHER

Oral nicotine pouches that contain 3 mg of nicotine

3 mg + Smooth flavor; 3 mg + Wintergreen flavor

6 mg nicotine pouch OTHER

Oral nicotine pouches that contain 6 mg of nicotine

6 mg + Smooth flavor; 6 mg + Wintergreen flavor

Smooth nicotine pouch OTHER

Non-flavored nicotine pouches that are characterized as smooth.

0 mg + Smooth flavor; 3 mg + Smooth flavor; 6 mg + Smooth flavor

Wintergreen nicotine pouch OTHER

Menthol flavored nicotine pouches that are characterized as wintergreen.

0 mg + Wintergreen flavor; 3 mg + Wintergreen flavor; 6 mg + Wintergreen flavor

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jonathan Foulds, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolle M Krebs, MS

CONTACT

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

Jonathan Foulds, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 17, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the completion of the main outcome analysis proposed in this study
• Access Criteria: Requests for de-identified individual participant data and/or study documents will be considered. The requestor must submit a 1-page abstract of their proposed research, including purpose, analytical plan, and dissemination plans. The Leadership Committee of the Penn State Center for Research on Tobacco and Health will review the abstract and decide based on the individual merits. Review criteria and prioritization of projects include potential of the proposed work to advance public health, qualifications of the applicant, the potential for publication, the potential for future funding, and enhancing the scientific, geographic, and demographic diversity of the research portfolio. Following abstract approval, requestors must receive institutional ethics approval or confirmation of exempt status for the proposed research. An executed data use agreement must be completed prior to data distribution.

Locations

US (2)