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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: Recruiting Phase 4 study of Smoking Cessation and Smoker, sponsored by University of Wisconsin, Madison.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Participants will self-report on their cigarette use
Conditions Studied
Interventions
- DRUG Nicotine Pouches
- DRUG Mini Nicotine lozenges
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-05-21 |
| Est. Completion | 2029-07-30 |
| Phase | Phase 4 |
What NCT06595459 shows while recruiting
NCT06595459 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (37% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06595459's enrollment target sits among peer trials
300 80th of 188 higher than 107 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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