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 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.
|Nicotine Dependence||Biological: NicVAX Radiation: [123I]5-IA-85380 Drug: Nicotine bitartrate||Phase 2|
|Study Design:||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|
- 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.
|Study Start Date:||September 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996034
|United States, Connecticut|
|Veterans Association Connecticut Hospital System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Irina Esterlis, Ph.D.||Yale University|