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A Fmri Study on the Effects of a Conjugate Vaccine and Placebo on CNS Activation and Behavior Following a Nicotine Challenge

NCT01318668 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2013-03-04

No results posted yet for this study

Summary

In this study the effects of a nicotine challenge on brain activity, behavior and mood will be evaluated in two groups of healthy volunteers who have a smoking habbit: The first group will undergo a series of treatments with NicVax, aimed at producing nicotine antibodies in the body and preventing nicotine to enter the brain. The second group will receive a placebo treatment. This pre-treatment (vaccination) will take place over a 18-week period. All participants will then undergo two days of testing. On each day the subjects will perform a number of psychomotor and memory tests after a challenge with nicotine (gum) or placebo(gum). Also brain activity will be studied in an fMRI scanner. We expect to see an effect on brain activation and performance only in the placebo-vaccinated group. The Nicvax vaccinated group should show activation and performance comparable to that after challenge with placebo(gum) as in this group nicotine should not cross the blood brain barrier and enter the brain

Conditions

  • Nicotine Dependency
  • Smoking

Interventions

BIOLOGICAL

vaccination with Nicvax

5 vaccinations of NicVax 400ug (1 ml) over a 18 week period or matching placebo.

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Netherlands

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 NCT01318668 on ClinicalTrials.gov