Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05683821 · ClinicalTrials.gov registry record · Phase 4
BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 12,376
- Enrollment target
NCT05683821: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT05683821 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 12,376 participants, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (2294% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05683821, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12,376 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.
Primary Outcome
The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.
Interventions
- BEHAVIORAL Text message smoking treatment
- DRUG Nicotine replacement therapy sampling
- COMBINATION_PRODUCT Wisconsin Tobacco QuitLine Referral
- COMBINATION_PRODUCT Referral to Primary Care Provider
- COMBINATION_PRODUCT BREATHE 2 Cessation Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,376 participants |
| Start Date | 2023-07-24 |
| Est. Completion | 2025-05-07 |
| Phase | Phase 4 |
What the finished NCT05683821 record still lists
NCT05683821 is an interventional study that assigns participants to a tested intervention. Its 12,376 participants enrollment target places it among the larger protocols in the corpus, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (2294% higher).
The record links to 0 conditions, and to 5 interventions - of which Text message smoking treatment is the first listed.
NCT05683821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05683821 about?
NCT05683821 is a clinical study titled "BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study". The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit sm...
What is the current status of trial NCT05683821?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12,376 participants. The study started on 2023-07-24. Estimated completion is 2025-05-07.
What interventions are being tested in trial NCT05683821?
The interventions under investigation include: Text message smoking treatment (BEHAVIORAL), Nicotine replacement therapy sampling (DRUG), Wisconsin Tobacco QuitLine Referral (COMBINATION_PRODUCT), Referral to Primary Care Provider (COMBINATION_PRODUCT), BREATHE 2 Cessation Study (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05683821?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05683821's enrollment target sits among peer trials
12,376 7th of 2000 higher than 1,994 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04888832 · 12,500 participants · NA
The Effect of Work Requirements in SNAP in Virginia
- NCT05452941 · 12,500 participants
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
- NCT07069556 · 12,500 participants
ColoSense Post-Approval Study
- NCT01772771 · 12,000 participants
Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI