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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: Completed Phase 3 study, sponsored by Duke University.
NCT01303861 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 702 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.
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 |
What the finished NCT01303861 record still lists
NCT01303861 is an interventional study that assigns participants to a tested intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Varenicline is the first listed.
NCT01303861 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01303861's enrollment target sits among peer trials
702 506th of 2000 higher than 1,495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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