The Options 2 Study

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

Conditions

Smoker, Smoking Cessation

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Study Overview

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Study Details

Study overview

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

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

The Options 2 Study

Condition
Smoker
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin, Madison, Wisconsin, United States, 53705

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

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

Study Record Dates

2026-10