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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 is a Phase 2 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 313 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00318383
The ClinicalTrials.gov registry entry for NCT00318383 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00318383 reports 0 study locations.
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.
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