NCT00996034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

December 24, 2015

Completed
Last Updated

December 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

October 14, 2009

Results QC Date

September 12, 2012

Last Update Submit

November 19, 2015

Conditions

Nicotine Dependence

Keywords

Nicotine, SPECT, vaccine, receptor

Outcome Measures

Primary Outcomes (1)

  • Mean of the Average Nicotine Binding % at Scan 1 and Scan 2

    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.

    3 months

Study Arms (1)

Healthy Smoker

EXPERIMENTAL

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

Biological: NicVAXRadiation: [123I]5-IA-85380Drug: Nicotine bitartrate

Interventions

NicVAXBIOLOGICAL

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

Also known as: Nicotine Conjugate Vaccine
Healthy Smoker
[123I]5-IA-85380RADIATION

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

Also known as: 5-IA
Healthy Smoker
Nicotine bitartrateDRUG

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

Also known as: IV nicotine
Healthy Smoker

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current smoker who smokes at least 10-25 cigarettes a day
  • Good general health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Association Connecticut Hospital System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 23429725DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

NicVAX5-iodo-3-(2-azetidinylmethoxy)pyridineNicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Irina Esterlis, Ph.D.
Organization
Yale University
irina.esterlis@yale.edu
203-932-5711

Study Officials

  • Irina Esterlis, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 16, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

December 24, 2015

Results First Posted

December 24, 2015

Record last verified: 2015-11

Locations

US(1)