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NCT01303861 · ClinicalTrials.gov registry record · Phase 3
Concurrent Bupropion / Varenicline for Smoking Cessation
A Phase 3 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 702
- Enrollment target
NCT01303861 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 702 participants.
The verdict
NCT01303861, a Phase 3 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 702 participants
- Enrollment target
Study Summary
This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design
Interventions
- DRUG Varenicline
- DRUG Bupropion
- DRUG Nicotine patches
- DRUG Nicotine Inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01303861
The ClinicalTrials.gov registry entry for NCT01303861 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 702 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Varenicline is the first listed.
NCT01303861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01303861 about?
NCT01303861 is a clinical study titled "Concurrent Bupropion / Varenicline for Smoking Cessation". This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in ...
What is the current status of trial NCT01303861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2011-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01303861?
The interventions under investigation include: Varenicline (DRUG), Bupropion (DRUG), Nicotine patches (DRUG), Nicotine Inhaler (DRUG).
Who is sponsoring clinical trial NCT01303861?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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