CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
NicVAX +2 morebiological
Likely dose
NicVAX 1.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00996034
NCT00996034Phase 2Completed
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123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine

Yale University·interventional·Posted Oct 16, 2009·Updated Dec 24, 2015

In Brief

A Phase 2 clinical trial evaluating NicVAX, [123I]5-IA-85380, and 1 other intervention for Nicotine Dependence. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
CollaboratorsNabi Biopharmaceuticals, National Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2009
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.7 years ago

Interventions

NicVAXbiological

1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies

[123I]5-IA-85380radiation

up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days

Nicotine bitartratedrug

0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days