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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 (EPU057)

This study has been completed.
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Vuurman, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01318668
First received: March 17, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Nicotine Dependency
Smoking
 Biological: vaccination with Nicvax
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: An fMRI-study on the Effects of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein a Conjugate Vaccine (NicVAX®) and Placebo on Central Nervous System Activation and Behaviour Following a Nicotine Challenge

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • FMRI [ Time Frame: at 18 and 20 weeks post vaccination ] [ Designated as safety issue: No ]
    Regional blood oxygenated level dependent (BOLD) response (method: BOLD functional MRI) during resting state and during task performance, in regions of interest, before and after nicotine administration.

  • Reaction time [ Time Frame: at 18 and 20 weeks post vaccination ] [ Designated as safety issue: No ]
    Task performance; the number of correct response and the reaction time in a battery of psycho-motor tests.


Secondary Outcome Measures:
  • Mood [ Time Frame: 18 and 20 weeks post vaccination ] [ Designated as safety issue: No ]
    Mood will be evaluated by means of questionnaires prior to and following the nicotine/placebo challenge


Enrollment: 38
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine vaccination
18 week treatment with Nicvax
 Biological: vaccination with Nicvax
5 vaccinations of NicVax 400ug (1 ml) over a 18 week period or matching placebo.
Other Name: NicVAX is a P. earoginosa r-Exoprotein conjugate vaccine.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health male right handed volunteers between 25-40 years of age.
  • Smoking at least 10 cigarettes per day

Exclusion Criteria:

  • Contra indications for MRI scanner
  • History of neurological or psychiatric disease
  • known immunodeficiency
  • current use of psychoactive medication
  • excessive alcohol use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318668

Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6226cc
Sponsors and Collaborators
Maastricht University Medical Center
Maastricht University
  More Information

No publications provided

Responsible Party: Vuurman, Dr Eric Vuurman, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01318668     History of Changes
Other Study ID Numbers: CCMO31915
Study First Received: March 17, 2011
Last Updated: March 1, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Maastricht University Medical Center:
fmri smoking vaccination mood

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013