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Nicotine Vaccination and Nicotinic Receptor Occupancy

NCT ID: NCT00996034

Last Updated: 2015-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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

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Nicotine Dependence

Keywords

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Nicotine, SPECT, vaccine, receptor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Healthy Smoker

There is only one arm to the study. All subjects will receive NicVax, \[123I\]5-I-A-85380,and Nicotine bitartrate.

Group Type EXPERIMENTAL

NicVAX

Intervention Type BIOLOGICAL

1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies

[123I]5-IA-85380

Intervention Type RADIATION

up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days

Nicotine bitartrate

Intervention Type DRUG

0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days

Interventions

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NicVAX

1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies

Intervention Type BIOLOGICAL

[123I]5-IA-85380

up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days

Intervention Type RADIATION

Nicotine bitartrate

0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days

Intervention Type DRUG

Other Intervention Names

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Nicotine Conjugate Vaccine 5-IA IV nicotine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irina Esterlis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Veterans Association Connecticut Hospital System

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Esterlis I, Hannestad JO, Perkins E, Bois F, D'Souza DC, Tyndale RF, Seibyl JP, Hatsukami DM, Cosgrove KP, O'Malley SS. Effect of a nicotine vaccine on nicotine binding to beta2*-nicotinic acetylcholine receptors in vivo in human tobacco smokers. Am J Psychiatry. 2013 Apr;170(4):399-407. doi: 10.1176/appi.ajp.2012.12060793.

Reference Type DERIVED
PMID: 23429725 (View on PubMed)

Other Identifiers

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R21DA024388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0804003655

Identifier Type: -

Identifier Source: org_study_id