NCT06595459

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
39mo left

Started May 2025

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
May 2025Jul 2029

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2029

Last Updated

September 4, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

September 10, 2024

Last Update Submit

September 2, 2025

Conditions

SmokerSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Mean number of cigarettes smoked per day during the 21-day switching period.

    Participants will self-report on their cigarette use

    Baseline to 3 weeks

Secondary Outcomes (3)

  • Change in cigarette craving

    Baseline to 3 weeks

  • Mean units of study product used per day during the 7-days prior to the switching period

    For 7-days leading up to the switching period

  • Mean units of study product used per day during the 21-day of the switching period

    21-days of the switching period

Study Arms (4)

3mg Nicotine Pouches

EXPERIMENTAL

Participants will use 3mg nicotine pouches

Drug: Nicotine Pouches

6mg Nicotine Pouches

EXPERIMENTAL

Participants will use 6mg nicotine pouches

Drug: Nicotine Pouches

Nicotine Mini Lozenges

EXPERIMENTAL

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

Drug: Mini Nicotine lozenges

No Study Product

NO INTERVENTION

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

Interventions

Nicotine PouchesDRUG

3mg or 6mg nicotine pouches

Also known as: ZYN
3mg Nicotine Pouches6mg Nicotine Pouches
Mini Nicotine lozengesDRUG

2mg to 4mg mini lozenges

Nicotine Mini Lozenges

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Megan Piper, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Piper, PhD

CONTACT

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

Mark Zehner

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

May 21, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 30, 2029

Last Updated

September 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)