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
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependency Smoking||Biological: vaccination with Nicvax||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|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|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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.
- 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.
- 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.
- 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
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
|Maastricht, Limburg, Netherlands, 6226cc|