Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT06595459

Conditions

Smoker

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Nicotine Pouches

Mini Nicotine lozenges

Study Details

Brief summary:

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

Study ID

NCT06595459

Start date

May 21, 2025

Status verified date

Jun, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3mg Nicotine Pouches

Participants will use 3mg nicotine pouches

experimental: 6mg Nicotine Pouches

Participants will use 6mg nicotine pouches

experimental: Nicotine Mini Lozenges

Participants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg)

no intervention: No Study Product

Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.

Interventions

Nicotine Pouches

nicotine pouches

Mini Nicotine lozenges

mini lozenges

Primary outcome measure

  • Mean number of cigarettes smoked per day during the 21-day switching period. [ Time Frame: Baseline to 3 weeks ]

Central Contacts and Locations

Central contacts

Megan Piper, PhD

608-265-5472mep@ctri.wisc.edu

Mark Zehner

608-262-7568mark.zehner@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Megan Piper, PhD

608-265-5472mep@ctri.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-22.