Social Cognition,Attentional Network and Nicotine Drug Dependency - A Pharmacological Clinical Trail
Condition: Tobacco Use Disorder; Schizophrenia
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): nicotine nasal spray
Intervention type(s): Drug
Intervention description(s): 0,5 mg nicotine nasal spray or placebo (pepperspray)
Other intervention name(s): nicorette nasal spray
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science