Trial document





This trial has been registered retrospectively.
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  DRKS00004529

Trial Description

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Title

Role of the nicotinic cholingergic System in top down and bottom up control of attention

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of the study is to investigate the role of the neurotransmitter acetylcholine in attention. Three experiments will be performed using an attentional task while volunteers receive either nicotine or placebo. Nicotine acts on one of the receptors for the neurotransmitter acetylcholine. In the first experiment, we will investigate effects of nicotine on reaction times, in the second on brain activity using functional magnetic resonance imaging (fMRI). Further, the role of a variation in a nicotinic receptor gene will be investigated. Finally we will use transcranial magnetic stimulation (TMS) to pertub brain areas and investigate the effects of such pertubation on attention. In sum, the study should contribute to our understanding of the neurotransmitter acetylcholine in attention.

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Brief Summary in Scientific Language

Aim of the study is to investigate the role of the cholinergic neurotransmitter system in attention. We aim to combine pharmacological and genetic neuroimaging approaches. Three experiments will be performed using a visual search paradgim with varying demands on top down and bottom up attentional control. We will use the cholinergic agonist nicotine, to experimentally manipulate cholinergic neurotransmission. The role of the nicotinic receptor gene CHRNA4 will be investigated. Behaviourally we will assess reaction times. Neurally we will measure BOLD responses by means of fMRI. Finally we will use TMS to pertub brain areas in a genotpye-specific way. In sum, the study should contribute to our understanding of neurochemical modulation of attention.

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Organizational Data

  •   DRKS00004529
  •   2012/11/13
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  •   yes
  •   Approved
  •   CT012010, Ethik-Kommission der Deutschen Gesellschaft für Psychologie
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Secondary IDs

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Health Condition or Problem studied

  •   healthy volunteers
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Interventions/Observational Groups

  •   NiQuitin 7mg (GSK patch) 1 x 50 min
  •   placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Comparison nicotine-placebo. It is one measurement after acute application of the drug. Primary endpoint in fMRI is a significant change in BOLD activity in parietal cortex, on the behavioural side it is a significant change in reaction times in the experimental paradigm.

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Secondary Outcome

Comparison nicotine-placebo. It is one measurement after acute application of the drug. Secondary endpoint in fMRI is a significant change in BOLD activity in frontal and temporal cortex, on the behavioural side it is a significant change in accuracy and variability of reaction times in the experimental paradigm.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2011/05/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

MR compatible, healthy

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Exclusion Criteria

neurological or psychiatric disease, metal in body, intake of drugs, smoker, left handed

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Addresses

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    • Institut für Psychologie, Universität Oldenburg
    • Ms.  Prof. Dr.  Christiane  Thiel 
    • Ammerländer Herr Str. 114-118
    • 26111  Oldenburg
    • Germany
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    • Insititut für Psychologie, Universität Oldenburg
    • Ms.  Prof. Dr.  Christiane  Thiel 
    • Ammerländer Herr Str. 114-118
    • 26111  Oldenburg
    • Germany
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    • Institit für Psychologie, Universität Oldenburg
    • Ms.  Prof.Dr.  Christiane  Thiel 
    • Ammerländer Herr Str. 114-118
    • 26111  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (DFG)
    • 53275  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.