NCT00996034

Nicotine Vaccination and Nicotinic Receptor Occupancy

123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist \[123I\]5-IA-85380 (\[123I\]5-IA) and single photon emission computed tomography (SPECT). \[123I\]5-IA will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). Three baseline SPECT images will be obtained after equilibrium has been reached (\~6 hours into the \[123I\]5-IA infusion). Then, IV nicotine will be administered (0.5-1.5 mg/70 kg will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second \[123I\]5-IA scan day. We hypothesize that occupancy of β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine administration.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
BIOLOGICAL	NicVAX	1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
RADIATION	[123I]5-IA-85380	up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days
DRUG	Nicotine bitartrate	0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-10-16
• Last updated: 2015-12-24
• Results posted: 2015-12-24

Locations

1 site across 1 country: United States