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Methods Project 4: Clinical Trial - Amended
NCT03111537 · View on ClinicalTrials.gov ↗
Study Summary
Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.
Conditions Studied
Interventions
- OTHER Cigarettes
- OTHER E-Cigarette
- OTHER Nicotine Gum or Lozenge
Study Locations (3)
Minnesota
- Masonic Cancer Center, University of Minnesota — Minneapolis
New York
- Roswell Park Cancer Center — Buffalo
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03111537
The ClinicalTrials.gov registry entry for NCT03111537 describes a study currently listed as completed. It is categorized as NA, 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 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Tobacco Smoking appearing as the primary indexed condition, and to 3 interventions — of which Cigarettes 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: NCT03111537 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Minnesota, New York, Ohio. 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 NCT03111537 about?
NCT03111537 is a clinical study titled "Methods Project 4: Clinical Trial - Amended". Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week inte...
What is the current status of trial NCT03111537?
This trial is currently completed. It is a NA study. The enrollment target is 264 participants. The study started on 2015-05. Estimated completion is 2018-02.
What conditions does trial NCT03111537 study?
This clinical trial studies the following conditions: Tobacco Smoking. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03111537?
The interventions under investigation include: Cigarettes (OTHER), E-Cigarette (OTHER), Nicotine Gum or Lozenge (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03111537?
This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03111537 being conducted?
This trial has 3 study locations across Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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