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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)

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ClinicalTrials.gov Identifier: NCT01318668
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : March 4, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Nicotine Dependency Smoking Biological: vaccination with Nicvax Phase 1 Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. FMRI [ Time Frame: at 18 and 20 weeks post vaccination ]
    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.

  2. Reaction time [ Time Frame: at 18 and 20 weeks post vaccination ]
    Task performance; the number of correct response and the reaction time in a battery of psycho-motor tests.


Secondary Outcome Measures :
  1. Mood [ Time Frame: 18 and 20 weeks post vaccination ]
    Mood will be evaluated by means of questionnaires prior to and following the nicotine/placebo challenge


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318668


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vuurman, Dr Eric Vuurman, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01318668     History of Changes
Other Study ID Numbers: CCMO31915
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Vaccines
Nicotine
Immunologic Factors
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action