Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 313 participants
Start Date 2006-05
Est. Completion 2007-12
Phase Phase 2

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.