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Improving the Efficacy of Anti-Nicotine Immunotherapy

NCT01280968 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-03-05

Study results available
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Summary

The purpose of this study is to find out how vaccine-induced antibodies change the way the body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine accumulation and distribution of nicotine between the brain and other body tissues. This vaccine is investigational which means that it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.

Conditions

  • Nicotine Dependence

Interventions

BIOLOGICAL

NIC002 in Aluminum hydroxide (Alum)

Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.

BIOLOGICAL

Placebo Vaccine - Aluminum hydroxide

Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Alexey Mukhin

    lead OTHER

Principal Investigators

  • Alexey G Mukhin, M.D., Ph.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-09-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01280968 on ClinicalTrials.gov