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Nicotine Vaccination and Nicotinic Receptor Occupancy

This study has been completed.
Sponsor:
Collaborator:
Nabi Biopharmaceuticals
Information provided by (Responsible Party):
Irina Esterlis, Yale University
ClinicalTrials.gov Identifier:
NCT00996034
First received: October 14, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Nicotine Dependence
 Biological: NicVAX
Radiation: [123I]5-IA-85380
Drug: Nicotine bitartrate
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Brain nicotine acetylcholine receptor occupancy before and after vaccine administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of brain nicotine acetylcholine receptor occupancy with behavioral characteristics of smoking [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy Smoker
Healthy smokers with nicotine dependence
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996034

Locations
United States, Connecticut
Veterans Association Connecticut Hospital System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Nabi Biopharmaceuticals
Investigators
Principal Investigator: Irina Esterlis, Ph.D. Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Irina Esterlis, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00996034     History of Changes
Other Study ID Numbers: 0804003655, NicVax
Study First Received: October 14, 2009
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013