Social Cognition,Attentional Network and Nicotine Drug Dependency - A Pharmacological Clinical Trail

NCT ID: NCT00618280

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-08-31

Brief Summary

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.

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.

Conditions

Tobacco Use Disorder; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

nicotine nasal spray

Intervention Type: DRUG

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

2

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

Group Type: PLACEBO_COMPARATOR

nicotine nasal spray

Intervention Type: DRUG

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

Interventions

nicotine nasal spray

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

Intervention Type: DRUG

Other Intervention Names

nicorette nasal spray

Eligibility 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 pharmacological trials within 6 weeks
• negative pregnancy test
• use of effective contraception 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 preparation
• adenoids
• Rhinitis vaso.
• hypersensitivity of air passages
• cardiovascular diseases (defined)
• neurological diseases (defined)
• diabetes mellitus
• hyperthyreosis
• phaeochromocytoma
• Clozapine (schizophrenic)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

G. Winterer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy

Locations

Psychiatrische Klinik und Poliklinik der Heinrich-Heine-Universität

Düsseldorf, North Rhine-Westphalia, Germany

Forschungszentrum Jülich GmbH

Jülich, North Rhine-Westphalia, Germany

Countries

Germany

References

Warbrick T, Mobascher A, Brinkmeyer J, Musso F, Stoecker T, Shah NJ, Fink GR, Winterer G. Nicotine effects on brain function during a visual oddball task: a comparison between conventional and EEG-informed fMRI analysis. J Cogn Neurosci. 2012 Aug;24(8):1682-94. doi: 10.1162/jocn_a_00236. Epub 2012 Mar 27.

Reference Type: DERIVED

PMID: 22452559 (View on PubMed)

Luckhaus C, Henning U, Ferrea S, Musso F, Mobascher A, Winterer G. Nicotinic acetylcholine receptor expression on B-lymphoblasts of healthy versus schizophrenic subjects stratified for smoking: [3H]-nicotine binding is decreased in schizophrenia and correlates with negative symptoms. J Neural Transm (Vienna). 2012 May;119(5):587-95. doi: 10.1007/s00702-011-0743-1. Epub 2011 Dec 11.

Reference Type: DERIVED

PMID: 22160487 (View on PubMed)

Related Links

http://www.nicotine-research.com

Related Info

Other Identifiers

NIKOGEN_HHU_2006

Identifier Type: -

Identifier Source: org_study_id