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The Options 2 Study

NCT06595459 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

DRUG

Nicotine Pouches

3mg or 6mg nicotine pouches

DRUG

Mini Nicotine lozenges

2mg to 4mg mini lozenges

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Megan Piper, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2029-01-01
Completion
2029-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06595459 on ClinicalTrials.gov