Nicotine Vaccination and Nicotinic Receptor Occupancy
- Conditions
- Nicotine Dependence
- Interventions
- Registration Number
- NCT00996034
- Lead Sponsor
- Yale University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Current smoker who smokes at least 10-25 cigarettes a day
- Good general health
- Subjects with a pacemaker or other ferromagnetic material in body.
- Prior exposure to NicVAX or any other nicotine vaccine.
- Use of systemic steroids or other immunosuppressive agent
- History of significant neurological, cardiovascular, hepatic, endocrine, renal, liver, psychiatric or thyroid illness
- Cancer or cancer treatment in last 5 years
- HIV infection
- Use of varenicline (Chantix), bupropion (Wellbutrin, Zyban), mecamylamine (Inversin), within 30 days prior to administration of NicVAX and for the duration of the study.
- Inability to fulfill all visits and examination procedures for approximately 20 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy Smoker NicVAX There is only one arm to the study. All subjects will receive NicVax, \[123I\]5-I-A-85380,and Nicotine bitartrate. Healthy Smoker [123I]5-IA-85380 There is only one arm to the study. All subjects will receive NicVax, \[123I\]5-I-A-85380,and Nicotine bitartrate. Healthy Smoker Nicotine bitartrate There is only one arm to the study. All subjects will receive NicVax, \[123I\]5-I-A-85380,and Nicotine bitartrate.
- Primary Outcome Measures
Name Time Method Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Veterans Association Connecticut Hospital System
🇺🇸West Haven, Connecticut, United States