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Search / Trial NCT06595459

The Options 2 Study

Launched by UNIVERSITY OF WISCONSIN, MADISON · Sep 10, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

The Options 2 Study is a clinical trial looking at how effective nicotine pouches and mini lozenges are as alternatives for people trying to quit smoking cigarettes. If you are a smoker who has been smoking at least 5 cigarettes a day for the past six months and are over 21 years old, you might be eligible to participate. Participants in the study will use either the nicotine products or no product at all for a week, then try to stop smoking for the following three weeks.

During the trial, you would need to attend six in-person visits and one follow-up call, where you'll answer questions and use a smartphone app to track your smoking and product use. It's important to note that you should not have any plans to quit smoking in the next month and must be willing to stop other nicotine replacements if you're currently using them. This study is not recruiting participants yet, but it aims to help understand better ways to help smokers switch to less harmful products.

Gender

ALL

Eligibility criteria

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

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Megan Piper, PhD

Principal Investigator

University of Wisconsin, Madison

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported