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Nicotine Vaccination and Nicotinic Receptor Occupancy

NCT00996034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-12-24

Study results available
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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.

Conditions

  • Nicotine Dependence

Interventions

BIOLOGICAL

NicVAX

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

RADIATION

[123I]5-IA-85380

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

DRUG

Nicotine bitartrate

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

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Irina Esterlis, Ph.D. · Yale University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996034 on ClinicalTrials.gov