RECRUITING

Use of Nicotine Pouches Among Daily Smokers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers

Quick Facts

Study Start:2024-09-17
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06043362

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.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months
  2. * Exhaled CO measurement of ≥ 6 parts per million at baseline
  3. * Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches
  4. * Able to understand, read and write in English
  5. * Access to e-mail and a smartphone/computer that has reliable internet connection
  6. * Able to understand and give informed consent
  1. * Plans to quit smoking within the next 30 days
  2. * Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months
  3. * 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)
  4. * 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
  5. * 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
  6. * Use of illegal drugs daily or weekly in the past 3 months
  7. * 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)
  8. * Other member of the household currently participating in the study
  9. * Any other condition that in the opinion of the investigator would make it unlikely that the participant could comply with the study protocol

Contacts and Locations

Study Contact

Nicolle M Krebs, MS
CONTACT
717-531-5673
nkrebs@pennstatehealth.psu.edu
Jonathan Foulds, PhD
CONTACT
717-531-3504
jfoulds@pennstatehealth.psu.edu

Principal Investigator

Jonathan Foulds, PhD
PRINCIPAL_INVESTIGATOR
Penn State College of Medicine

Study Locations (Sites)

Penn State College of Medicine
Hershey, Pennsylvania, 17033
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2028-08

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

  • Tobacco Dependence