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NCT00996034 · ClinicalTrials.gov registry record · Phase 2
Nicotine Vaccination and Nicotinic Receptor Occupancy
A Phase 2 study of Nicotine Dependence, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00996034: Completed Phase 2 study of Nicotine Dependence, sponsored by Yale University.
NCT00996034 is a Phase 2 study of Nicotine Dependence that has completed, run by Yale University. The registered enrollment target is 14 participants, below the 187-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996034, a Phase 2 study of Nicotine Dependence, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker. In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.
Primary Outcome
nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.
Conditions Studied
Interventions
- BIOLOGICAL NicVAX
- RADIATION [123I]5-IA-85380
- DRUG Nicotine bitartrate
Study Locations (1)
Connecticut
- Veterans Association Connecticut Hospital System - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT00996034 record still lists
NCT00996034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 187-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 3 interventions - of which NicVAX is the first listed.
NCT00996034 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT00996034 about?
NCT00996034 is a clinical study titled "Nicotine Vaccination and Nicotinic Receptor Occupancy". This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cess...
What is the current status of trial NCT00996034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2009-09. Estimated completion is 2011-02.
What conditions does trial NCT00996034 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT00996034?
The interventions under investigation include: NicVAX (BIOLOGICAL), [123I]5-IA-85380 (RADIATION), Nicotine bitartrate (DRUG).
Who is sponsoring clinical trial NCT00996034?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00996034 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00996034's enrollment target sits among peer trials
14 63rd of 67 higher than 3 of 67 other Nicotine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nicotine Dependence 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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