Use of Nicotine Pouches Among Daily Smokers

Description

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

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Study Overview

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Study Details

Study overview

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.

Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers

Use of Nicotine Pouches Among Daily Smokers

Condition
Tobacco Dependence
Intervention / Treatment

-

Contacts and Locations

Hershey

Penn State College of Medicine, Hershey, Pennsylvania, United States, 17033

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Milton S. Hershey Medical Center,

Jonathan Foulds, PhD, PRINCIPAL_INVESTIGATOR, Penn State College of Medicine

Study Record Dates

2028-08