RECRUITING

The Options 2 Study

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 goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products. Participants will: * Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use

Official Title

A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health

Quick Facts

Study Start:2025-05-21
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06595459

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 21 years old (i.e., able to legally purchase tobacco products)
  2. * able to read and communicate in English
  3. * no plans to quit smoking in the next 30 days
  4. * willing to stop using nicotine replacement or varenicline
  5. * willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
  6. * smoking ≥ 5 cigarettes per day for the past 6 months
  7. * exhaled carbon monoxide ≥ 6 ppm
  8. * no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months
  1. * currently in treatment for psychosis or bipolar disorder
  2. * currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
  3. * currently pregnant or breastfeeding

Contacts and Locations

Study Contact

Megan Piper, PhD
CONTACT
608-265-5472
mep@ctri.wisc.edu
Mark Zehner
CONTACT
608-262-7568
mark.zehner@wisc.edu

Principal Investigator

Megan Piper, PhD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Megan Piper, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

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 Date2025-05-21
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-05-21
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Smoker
  • Smoking Cessation