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NCT01341938 · ClinicalTrials.gov registry record · NA
Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
A NA study, sponsored by Oregon Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 1,067
- Enrollment target
NCT01341938: Completed NA study, sponsored by Oregon Research Institute.
NCT01341938 is a NA study that has completed, run by Oregon Research Institute. The registered enrollment target is 1,067 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01341938, a NA study, has completed, sponsored by Oregon Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,067 participants
- Enrollment target
Study Summary
This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions: 1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials 2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges 3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy. Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.
Primary Outcome
The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up.
Interventions
- DRUG Commit® nicotine lozenges (4 mg) & self-help materials
- BEHAVIORAL Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials
- BEHAVIORAL Phone counseling & self-help materials
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,067 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-11 |
| Phase | NA |
What the finished NCT01341938 record still lists
NCT01341938 is an interventional study that assigns participants to a tested intervention. Its 1,067 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 3 interventions - of which Commit® nicotine lozenges (4 mg) & self-help materials is the first listed.
NCT01341938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01341938 about?
NCT01341938 is a clinical study titled "Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation". This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions: 1. The Lozenge Assisted Self-help intervention...
What is the current status of trial NCT01341938?
This trial is currently completed. It is a NA study. The enrollment target is 1,067 participants. The study started on 2011-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01341938?
The interventions under investigation include: Commit® nicotine lozenges (4 mg) & self-help materials (DRUG), Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials (BEHAVIORAL), Phone counseling & self-help materials (BEHAVIORAL).
Who is sponsoring clinical trial NCT01341938?
This trial is sponsored by Oregon Research Institute, which has 62 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01341938's enrollment target sits among peer trials
1,067 97th of 2000 higher than 1,904 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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