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NCT01018394 · ClinicalTrials.gov registry record · Phase 2
Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT01018394: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT01018394 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01018394, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.
Primary Outcome
Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.
Interventions
- DRUG nicotine lozenges
- DRUG tobacco-free snuff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01018394 record still lists
NCT01018394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which nicotine lozenges is the first listed.
NCT01018394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01018394 about?
NCT01018394 is a clinical study titled "Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction". Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line...
What is the current status of trial NCT01018394?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2009-01. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01018394?
The interventions under investigation include: nicotine lozenges (DRUG), tobacco-free snuff (DRUG).
Who is sponsoring clinical trial NCT01018394?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01018394's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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