RECRUITING

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

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

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

Official Title

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches As a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)

Quick Facts

Study Start:2025-02-14
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06678789

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21+
  2. * current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
  3. * have not used TNFPs more than 5 times during their lifetime
  4. * willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
  5. * have internet access
  1. * Lack of proficiency in English.
  2. * Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
  3. * Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
  4. * Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
  5. * Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).

Contacts and Locations

Study Contact

Kathryn Moody
CONTACT
(843) 509-7589
moodykat@musc.edu

Principal Investigator

Amanda Palmer, PhD.
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Amanda Palmer, PhD., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Date2025-02-14
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2025-02-14
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Smoking

Additional Relevant MeSH Terms

  • Cigarette Smoking
  • Nicotine Dependence
  • Smoking Cessation