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NCT00894166 · ClinicalTrials.gov registry record · Phase 3
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
A Phase 3 study of Smoking Cessation, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 606
- Enrollment target
- 1
- Study location
NCT00894166: Completed Phase 3 study of Smoking Cessation, sponsored by Duke University.
NCT00894166 is a Phase 3 study of Smoking Cessation that has completed, run by Duke University. The registered enrollment target is 606 participants, above the 471-participant average among 188 other Smoking Cessation trials with a reported enrollment target (29% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00894166, a Phase 3 study of Smoking Cessation, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 606 participants
- Enrollment target
- 1
- Study location
Study Summary
Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit from prescription treatment alternatives, including Zyban or Chantix. In this study, the investigators propose to develop and evaluate a stepped-care treatment algorithm that would evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or switched to Chantix only based on: 1) their initial response to NRT; and 2) individual genetic factors found to predict smoking cessation in other studies evaluating these treatments. This study is a continuation of our previous studies showing that abstinence rates can be increased by starting nicotine patch therapy two weeks before the quit date. The investigators will provide pre-cessation NRT to all participants initially. Those who do not show a favorable response on early indicators of success (e.g., smoking in the first week after the target quit-smoking date) will receive "rescue" treatment by having their NRT treatment supplemented with Zyban , by being switched to treatment with Chantix or will remain on NRT (control). The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or Chantix will increase success rates over leaving subjects on NRT when they are NRT insufficient responders, i.e. they have shown an unfavorable response to NRT in the first week pre-quit or the first week post-quit.
Primary Outcome
A self report of no cigarettes smoked confirmed by expired air carbon monoxide of \<=10ppm was the criterion for abstinence.
Conditions Studied
Interventions
- DRUG Nicotine Patches
- DRUG Nicotine patches, then bupropion & nicotine patches (Pre-Quit)
- DRUG Nicotine patches, then varenicline (Pre-Quit)
- DRUG Nicotine patches, then nicotine patches (Pre-Quit)
- DRUG Nicotine patches, then bupropion & nicotine patches (Post-Quit)
Study Locations (1)
North Carolina
- Duke Center for Nicotine & Smoking Cessation Research - Charlotte, Durham, Raleigh, Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT00894166 record still lists
NCT00894166 is an interventional study that assigns participants to a tested intervention. The registered 606 participants enrollment target is mid-sized for trials with a published cap, above the 471-participant average among 188 other Smoking Cessation trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 5 interventions - of which Nicotine Patches is the first listed.
NCT00894166 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00894166 about?
NCT00894166 is a clinical study titled "Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype". Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit from prescription treatment alternatives, including Zyban or Chantix. In this study, the investigators propose to develop...
What is the current status of trial NCT00894166?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2009-05. Estimated completion is 2011-10.
What conditions does trial NCT00894166 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT00894166?
The interventions under investigation include: Nicotine Patches (DRUG), Nicotine patches, then bupropion & nicotine patches (Pre-Quit) (DRUG), Nicotine patches, then varenicline (Pre-Quit) (DRUG), Nicotine patches, then nicotine patches (Pre-Quit) (DRUG), Nicotine patches, then bupropion & nicotine patches (Post-Quit) (DRUG).
Who is sponsoring clinical trial NCT00894166?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00894166 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
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 NCT00894166's enrollment target sits among peer trials
606 47th of 188 higher than 142 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation 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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