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Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
NCT00894166 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00894166
The ClinicalTrials.gov registry entry for NCT00894166 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00894166 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00894166?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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