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NCT01314001 · ClinicalTrials.gov registry record · Phase 3
Pharmacogenetics of Nicotine Addiction Treatment
A Phase 3 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,246
- Enrollment target
NCT01314001: Completed Phase 3 study, sponsored by University of Pennsylvania.
NCT01314001 is a Phase 3 study that has completed, run by University of Pennsylvania. The registered enrollment target is 1,246 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314001, a Phase 3 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,246 participants
- Enrollment target
Study Summary
The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.
Primary Outcome
The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.
Interventions
- DRUG Placebo
- DRUG Varenicline
- DRUG Transdermal Nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,246 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01314001 record still lists
NCT01314001 is an interventional study that assigns participants to a tested intervention. Its 1,246 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01314001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01314001 about?
NCT01314001 is a clinical study titled "Pharmacogenetics of Nicotine Addiction Treatment". The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.
What is the current status of trial NCT01314001?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,246 participants. The study started on 2010-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01314001?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG), Transdermal Nicotine (DRUG).
Who is sponsoring clinical trial NCT01314001?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01314001's enrollment target sits among peer trials
1,246 210th of 2000 higher than 1,790 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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