A Fmri Study on the Effects of a Conjugate Vaccine and Placebo on CNS Activation and Behavior Following a Nicotine Challenge (EPU057)
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318668
|Maastricht, Limburg, Netherlands, 6226cc|