Nicotine Vaccination and Nicotinic Receptor Occupancy
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | February 2011 |
123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine
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.
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.
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.
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.
Inclusion Criteria:
- Current smoker who smokes at least 10-25 cigarettes a day
- Good general health
Exclusion Criteria:
- 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.
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