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NCT06595459 · ClinicalTrials.gov registry record · Phase 4

The Options 2 Study

A Phase 4 study of Smoking Cessation and Smoker, sponsored by University of Wisconsin, Madison.

Recruiting
Registry status
Phase 4
Development phase
300
Enrollment target
1
Study location

NCT06595459 is a Phase 4 study of Smoking Cessation and Smoker that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 300 participants, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06595459, a Phase 4 study of Smoking Cessation and Smoker, is actively recruiting participants, sponsored by University of Wisconsin, Madison.

RECRUITING
Registry status
Phase 4
Development phase
300 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG Nicotine Pouches
  • DRUG Mini Nicotine lozenges

Study Locations (1)

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2025-05-21
Est. Completion 2029-07-30
Phase Phase 4

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT06595459

The ClinicalTrials.gov registry entry for NCT06595459 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (37% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which Nicotine Pouches is the first listed.

NCT06595459 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT06595459 about?

NCT06595459 is a clinical study titled "The Options 2 Study". 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 stu...

What is the current status of trial NCT06595459?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2025-05-21. Estimated completion is 2029-07-30.

What conditions does trial NCT06595459 study?

This clinical trial studies the following conditions: Smoking Cessation, Smoker.

What interventions are being tested in trial NCT06595459?

The interventions under investigation include: Nicotine Pouches (DRUG), Mini Nicotine lozenges (DRUG).

Who is sponsoring clinical trial NCT06595459?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06595459 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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