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NCT00710034 · ClinicalTrials.gov registry record · Phase 2

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

A Phase 2 study of Tobacco Use Disorder, sponsored by University of Minnesota.

Completed
Registry status
Phase 2
Development phase
391
Enrollment target
2
Study locations

NCT00710034 is a Phase 2 study of Tobacco Use Disorder that has completed, run by University of Minnesota. The registered enrollment target is 391 participants, above the 234-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (67% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT00710034, a Phase 2 study of Tobacco Use Disorder, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
391 participants
Enrollment target
2
Study locations

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

FieldValue
Enrollment Target 391 participants
Start Date 2010-04
Est. Completion 2014-05
Phase Phase 2

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT00710034

The ClinicalTrials.gov registry entry for NCT00710034 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 391 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (67% higher). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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.

NCT00710034 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Oregon.

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.

What interventions are being tested in trial NCT00710034?

The interventions under investigation include: Nicotine Gum (DRUG), Oral tobacco (OTHER).

Who is sponsoring clinical trial NCT00710034?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.