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Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation
NCT00633321 · View on ClinicalTrials.gov ↗
Study Summary
Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year. This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL TA-NIC
Study Locations (9)
Maryland
- Columbia Medical Practice — Columbia
- Centennial Medical Group — Elkridge
Texas
- Benchmark Research — Austin
- Benchmark Research - Fort Worth — Fort Worth
California
- Benchmark Research — Sacramento
Louisiana
- Benchmark Research — Metairie
Minnesota
- Mayo Clinic — Rochester
New Jersey
- CNS Research Institute, P.C. — Clementon
Pennsylvania
- CRI Worldwide, LLC Kirkbride Center — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00633321
The ClinicalTrials.gov registry entry for NCT00633321 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 522 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celtic Pharma Development Services, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Smoking appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00633321 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Maryland, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00633321 about?
NCT00633321 is a clinical study titled "Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation". Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can...
What is the current status of trial NCT00633321?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 522 participants. The study started on 2007-05. Estimated completion is 2009-02.
What conditions does trial NCT00633321 study?
This clinical trial studies the following conditions: Smoking. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00633321?
The interventions under investigation include: Placebo (BIOLOGICAL), TA-NIC (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00633321?
This trial is sponsored by Celtic Pharma Development Services, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00633321 being conducted?
This trial has 9 study locations across California, Louisiana, Maryland, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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