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NCT00318383 · ClinicalTrials.gov registry record · Phase 2
Efficacy of NicVAX in Smokers Who Want to Quit Smoking
A Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 2
- Development phase
- 313
- Enrollment target
NCT00318383: Completed Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT00318383 is a Phase 2 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 313 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00318383, a Phase 2 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 313 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies. The primary study period is 12 months, which was extended by amendment to include up to 2 years of observations.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL NicVAX conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00318383 record still lists
NCT00318383 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00318383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00318383 about?
NCT00318383 is a clinical study titled "Efficacy of NicVAX in Smokers Who Want to Quit Smoking". The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing ...
What is the current status of trial NCT00318383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 313 participants. The study started on 2006-05. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00318383?
The interventions under investigation include: Placebo (BIOLOGICAL), NicVAX conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00318383?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00318383's enrollment target sits among peer trials
313 161st of 2000 higher than 1,840 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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