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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: Completed Phase 2 study of Tobacco Use Disorder, sponsored by University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects using only the assigned study product at week 6
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 |
What the finished NCT00710034 record still lists
NCT00710034 is an interventional study that assigns participants to a tested intervention. The registered 391 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (67% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00710034's enrollment target sits among peer trials
391 11th of 70 higher than 60 of 70 other Tobacco Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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