Nicotine Vaccination and Nicotinic Receptor Occupancy
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|ClinicalTrials.gov Identifier: NCT00996034|
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Biological: NicVAX Radiation: [123I]5-IA-85380 Drug: Nicotine bitartrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: Healthy Smoker
There is only one arm to the study. All subjects will receive NicVax, [123I]5-I-A-85380,and Nicotine bitartrate.
1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
Other Name: Nicotine Conjugate VaccineRadiation: [123I]5-IA-85380
up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days
Other Name: 5-IADrug: Nicotine bitartrate
0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
Other Name: IV nicotine
- Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996034
|United States, Connecticut|
|Veterans Association Connecticut Hospital System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Irina Esterlis, Ph.D.||Yale University|