This regulatory report summarizes the ClinicalTrials.gov record for the not yet recruiting smoking cessation study My Path to Quit Tobacco, detailing the interventions and sponsor context.
In the regulatory context this record presents a plan that combines pharmacologic therapy and behavioral supports to help individuals quit smoking. The interventions listed include a nicotine patch, quitline counseling phone calls, counseling sessions, Pathways to Freedom, and a monetary incentive. The sponsors named are University of Wisconsin Madison and the Patient Centered Outcomes Research Institute. The trial identifier is NCT07419425 and the public status is not yet recruiting. The source describes these elements without posting device specific performance data.
What is the My Path to Quit Tobacco study and why does it matter?
The record describes a smoking cessation focus with a multimodal approach. It lists pharmacologic and behavioral methodologies rather than a single product. This framing aligns with modern efforts to evaluate practical cessation strategies in real world settings. The not yet recruiting status indicates this work is in early stages and has not yet enrolled participants.
What interventions are included?
- Drug: Nicotine patch
- Other: Quitline Counseling Phone Calls
- Other: Counseling Sessions
- Other: Pathways to Freedom
- Other: Monetary Incentive
Who sponsors this trial and what is the regulatory framing?
Sponsors are University of Wisconsin Madison and the Patient Centered Outcomes Research Institute. The record shows not yet recruiting, reflecting early stage regulatory documentation. The mention of medical device in the source search is a keyword used for indexing and does not establish a device claim in the record. The entry is presented in plain language to support transparency and regulatory compliance.
Intended purpose and safety posture
The record indicates an intended purpose to support smoking cessation through a combination of pharmacologic and behavioral modalities. It does not provide device specific performance data or safety results. Any device classification statements would require separate documentation from the sponsor or manufacturer.
What is the recruitment status and next steps?
The status shown is Not yet recruiting. Next steps would include protocol readiness, ethics review where applicable, site selection and participant recruitment, followed by data collection and eventual result reporting if the study proceeds. Stakeholders should verify current status via the official ClinicalTrials.gov page linked in the source text.
What does this mean for clinicians and patients?
Clinicians may notice a focus on combining a nicotine patch with behavioral supports and incentives to improve quit rates. The involvement of a major university and a patient centered outcomes research institute signals interest in practical effects on patient outcomes. At this stage no results are available and no device level data are disclosed. Practitioners should await official study results and regulatory disclosures before applying any conclusions to practice.
- 1. What is the formal title of the study My Path to Quit Tobacco as described in the ClinicalTrials.gov record.
- 2. What interventions are listed Nicotine patch, quitline counseling phone calls, counseling sessions, Pathways to Freedom, monetary incentive.
- 3. Who sponsors the trial University of Wisconsin Madison and the Patient Centered Outcomes Research Institute.
- 4. What is the recruitment status Not yet recruiting as indicated in the record.
- 5. Where can I find the official record The ClinicalTrials.gov page referenced by the link in the source text, NCT07419425.
Conclusion and next steps
This article provides a regulatory oriented summary of a not yet recruiting smoking cessation trial that uses a combination of pharmacologic and behavioral strategies. Stakeholders should monitor the ClinicalTrials.gov page for updates on status, recruitment progress, and posted results. The collaboration between a university and a patient centered outcomes research institute reinforces a focus on patient outcomes.
Disclaimer and professional note
Not legal advice. This article is for regulatory and clinical professionals and is based on the source text only. For current status and guidance please refer to official records.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07419425?term=medical+device