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Sponsors and Collaborators: |
Heinrich-Heine University, Duesseldorf German Research Foundation |
Information provided by: | Heinrich-Heine University, Duesseldorf |
ClinicalTrials.gov Identifier: | NCT00618280 |
In the present study, we investigate healthy subjects and schizophrenic patients who frequently show very low attentional capacity with functional magnetic resonance imaging (fMRI) and electrophysiology (EEG) during attention-requiring tasks to assess the level of attentional network activity.
Condition | Intervention | Phase |
Tobacco Use Disorder Schizophrenia |
Drug: nicotine nasal spray |
Phase I Phase II |
MedlinePlus related topics: | MRI Scans Schizophrenia |
ChemIDplus related topics: | Nicotine polacrilex Nicotine tartrate Salicylsalicylic acid Sodium salicylate |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment |
Official Title: | Social Cognition,Attentional Network and Nicotine Drug Dependency - A Pharmacological Clinical Trail |
Estimated Enrollment: | 200 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
schizophrenic and non schizophrenic patient stratified by smoking and non smoking will get nicotine and placebo on first day on the second day placebo and nicotine
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Drug: nicotine nasal spray
0,5 mg nicotine nasal spray or placebo (pepperspray)
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2: Placebo Comparator
schizophrenic and non schizophrenic patient stratified by smoking and non smoking will get nicotine and placebo on first day on the second day placebo and nicotine
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Drug: nicotine nasal spray
0,5 mg nicotine nasal spray or placebo (pepperspray)
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Nicotine is improving attentional capacity which goes along with an activation of the attentional network in the brain. So far, however, it is unresolved whether nicotine is used for the purpose of self-medication by those nicotine-dependent subjects who suffer from subclinical or clinical attentional deficits which may sustain nicotine addiction. In the present study, we investigate healthy subjects and schizophrenic patients who frequently show very low attentional capacity with functional magnetic resonance imaging (fMRI) and electrophysiology (EEG) during attention-requiring tasks to assess the level of attentional network activity. It is anticipated that low attentional network activity (during baseline condition, after nicotine challenge and after withdrawal) predicts the degree of nicotine dependence including the strength of withdrawal symptoms and relapse rate after smoking cessation. In addition, we expect that functional variations within alpha4beta2 nAch receptor genotype are associated with attentional capacity and -by extension - with nicotine dependence.
Additionally Self-medication of attentional deficits and of increased stress vulnerability may contribute to nicotine-dependence both in schizophrenia patients and healthy subjects. However, very little is known about the effect of nicotine on stress in schizophrenia. In particular social stressors are highly relevant in schizophrenia often resulting in social withdrawal. A factor contributing to the stress-eliciting nature of social interaction is the misidentification of social information during communication with others. The present project aims at an investigation of nicotine effects on such social information processing and its neurophysiological correlates and on social stress responses. Using a 2x2-factorial design effects of nicotine vs. placebo are experimentally investigated in smoking schizophrenia patients in comparison to smoking healthy controls each after an overnight smoking deprivation. Nicotine will be administered by nasal spray delivering a systemic does of 2 mg nicotine. Event-related EEG potentials will be recorded during the presentation of pictures of facial affect and neutral control stimuli to assess social information processing and its neurophysiological correlates. In addition a videotaped semi-standardized conversation skills role-play test will be used as a social stress situation to assess self-reported and non-verbal affective responses.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: G. Winterer, Prof. Dr. | 0049-2119223463 | georg.winterer@uni-duesseldorf.de |
Contact: G. Fink, Prof. Dr. | 0049-2461614334 | g.r.fink@fz-juelich.de |
Germany, NW | |||||
Psychiatrische Klinik und Poliklinik der Heinrich-Heine-Universität | Recruiting | ||||
Duesseldorf, NW, Germany, 40629 | |||||
Contact: W. Wölwer, PD Dr. 0049-2119222002 woelwer@uni-duesseldorf.de | |||||
Sub-Investigator: W. Wölwer, PD Dr. | |||||
Forschungszentrum Jülich GmbH | Recruiting | ||||
Jülich, NW, Germany, 52425 | |||||
Contact: G. Fink, Prof. Dr. 0049-2461613015 g.r.fink@fz-juelich.de | |||||
Sub-Investigator: G. Fink, Prof. Dr. |
Heinrich-Heine University, Duesseldorf |
German Research Foundation |
Principal Investigator: | G. Winterer, Prof. Dr. | Department of Psychiatry and Psychotherapy |
Responsible Party: | Heinrich-Heine University, Duesseldorf Department of Psychiatry and Psychotherapy ( Heinrich-Heine University represented by principal investigator Prof. Winterer ) |
Study ID Numbers: | NIKOGEN_HHU_2006 |
First Received: | February 8, 2008 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00618280 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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