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Social Cognition,Attentional Network and Nicotine Drug Dependency - A Pharmacological Clinical Trail (NIKOGEN)
This study is currently recruiting participants.
Verified by Heinrich-Heine University, Duesseldorf, February 2008
Sponsors and Collaborators: Heinrich-Heine University, Duesseldorf
German Research Foundation
Information provided by: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00618280
  Purpose

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
Drug Information available for: Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
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

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Effect of nicotine or placebo in healthy subjects and schizophrenic patients on attentional network activity in brain with functional magnetic resonance imaging and EEG [ Time Frame: after last subject out ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • -Effect of nicotine on a4b2 nAch receptor genotype -Gene Expression of a4b2 nAch -effect of 24 h nicotine witdrawal on modulation special hormones -effect of nicotine on neurophysiological correlates of social stress [ Time Frame: after last subject out ] [ Designated as safety issue: No ]

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
Drug: nicotine nasal spray
0,5 mg nicotine nasal spray or placebo (pepperspray)
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
Drug: nicotine nasal spray
0,5 mg nicotine nasal spray or placebo (pepperspray)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-55
  • informed consent
  • negative drug-screening (cannabis, amphetamine, opiate, cocaine)
  • no drug abuse in medical history for last 6 month
  • no participation of subjects in other pharmcological trials within 6 weeks
  • negative pregnancy test
  • use of effective contaception within participation of trial
  • normotonia (heart rate, RR)
  • nicotine dependence (Fagerström >4)or not more than 20 cigarettes /lifetime
  • nicotine (smoker serum > 2ng/mL)
  • DSM-IV criteria for schizophrenia
  • healthy subjects

Exclusion Criteria:

  • known hypersensitivity towards nicotine or any substance of placebo preperation
  • adenoids
  • Rhinitis vaso.
  • hypersensitivity of air passages
  • cardiovascular diseases (defined)
  • neurological diseases (defined)
  • diabetes mellitus
  • hyperthreosis
  • praechromocytome
  • Clozapine (schizophrenic)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618280

Contacts
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

Locations
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.            
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Research Foundation
Investigators
Principal Investigator: G. Winterer, Prof. Dr. Department of Psychiatry and Psychotherapy
  More Information

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
Study First Received: February 8, 2008
Last Updated: February 8, 2008
ClinicalTrials.gov Identifier: NCT00618280  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Nicotine polacrilex
Schizophrenia
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

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

ClinicalTrials.gov processed this record on January 16, 2009