Actively Recruiting

Phase 4
Age: 21Years +
All Genders
NCT06595459

The Options 2 Study

Led by University of Wisconsin, Madison · Updated on 2025-09-04

300

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The Options 2 Study

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 21 years old or older (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 if currently used for smoking cessation only
  • Smoking at least 5 cigarettes per day for the past 6 months
  • Exhaled carbon monoxide level of 6 ppm or higher
  • No use of nicotine pouches or smokeless tobacco including snus within the last 6 months
Not Eligible

You will not qualify if you...

  • Currently in treatment for psychosis or bipolar disorder
  • Currently taking bupropion for reasons other than smoking cessation
  • Currently pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Wisconsin

Madison, Wisconsin, United States, 53705

Actively Recruiting

Loading map...

Research Team

M

Megan Piper, PhD

CONTACT

M

Mark Zehner

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here