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Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
NCT00710034 · View on ClinicalTrials.gov ↗
Study Summary
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period. For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.
Conditions Studied
Interventions
- DRUG Nicotine Gum
- OTHER Oral tobacco
Study Locations (2)
Minnesota
- University of Minnesota — Minneapolis
Oregon
- Oregon Research Institute — Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 391 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00710034
The ClinicalTrials.gov registry entry for NCT00710034 describes a study currently listed as completed. It is categorized as Phase 2, 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 391 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 Use Disorder appearing as the primary indexed condition, and to 2 interventions — of which Nicotine Gum 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: NCT00710034 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, Oregon. 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 NCT00710034 about?
NCT00710034 is a clinical study titled "Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine". For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; a...
What is the current status of trial NCT00710034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 391 participants. The study started on 2010-04. Estimated completion is 2014-05.
What conditions does trial NCT00710034 study?
This clinical trial studies the following conditions: Tobacco Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00710034?
The interventions under investigation include: Nicotine Gum (DRUG), Oral tobacco (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00710034?
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 NCT00710034 being conducted?
This trial has 2 study locations across Minnesota, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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