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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
Sponsor:
Collaborators:
Nabi Biopharmaceuticals
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Nicotine Dependence Biological: NicVAX Radiation: [123I]5-IA-85380 Drug: Nicotine bitartrate Phase 2

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.

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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Smoker
There is only one arm to the study. All subjects will receive NicVax, [123I]5-I-A-85380,and Nicotine bitartrate.
Biological: NicVAX
1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
Other Name: Nicotine Conjugate Vaccine

Radiation: [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-IA

Drug: Nicotine bitartrate
0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
Other Name: IV nicotine




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Connecticut
Veterans Association Connecticut Hospital System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Nabi Biopharmaceuticals
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Irina Esterlis, Ph.D. Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00996034     History of Changes
Other Study ID Numbers: 0804003655
R21DA024388 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2009    Key Record Dates
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015
Last Verified: November 2015

Keywords provided by Yale University:
Nicotine, SPECT, vaccine, receptor

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Vaccines
Nicotine
Immunologic Factors
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action