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COMPLETED Phase 4

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

NCT01553084 · View on ClinicalTrials.gov ↗

Study Summary

The overall purpose of this research is two-fold. First, the two smoking cessation medication treatments with the strongest evidence of effectiveness have never been directly compared. This research will determine how these two treatments compare in effectiveness in a head-to-head trial, and which types of smokers benefit most from each. Second, much of the data on smoking and health come from studies from many years ago. Today's smokers differ from earlier smokers in many ways that could influence the impact of smoking on health (e.g., weight, sex, diet, socio-economic status); the proposed work will determine how smoking cessation affects cardiovascular and pulmonary health in today's smokers.

Interventions

  • DRUG Varenicline
  • DRUG Nicotine Patch
  • DRUG Nicotine lozenge

Study Locations (2)

Wisconsin

  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health — Madison
  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health — Milwaukee

Trial Details

FieldValue
Enrollment Target 1,086 participants
Start Date 2012-05
Est. Completion 2017-08
Phase Phase 4

Sponsor

University of Wisconsin, Madison

943 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01553084

The ClinicalTrials.gov registry entry for NCT01553084 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,086 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Smoking Cessation appearing as the primary indexed condition, and to 3 interventions — of which Varenicline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01553084 reports 2 study locations spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01553084 about?

NCT01553084 is a clinical study titled "A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers". The overall purpose of this research is two-fold. First, the two smoking cessation medication treatments with the strongest evidence of effectiveness have never been directly compared. This research will determine how these two treatments compare in effectiveness in a head-to-head trial, and which t...

What is the current status of trial NCT01553084?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,086 participants. The study started on 2012-05. Estimated completion is 2017-08.

What conditions does trial NCT01553084 study?

This clinical trial studies the following conditions: Smoking Cessation, Smoking, Nicotine Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01553084?

The interventions under investigation include: Varenicline (DRUG), Nicotine Patch (DRUG), Nicotine lozenge (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01553084?

This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01553084 being conducted?

This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial