Trial document




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  DRKS00003388

Trial Description

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Title

Reward learning and extinction training in alcohol dependence: impact of
fronto-striatal connectivity

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Trial Acronym

SFB 636, D06

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URL of the Trial

http://www.sfb636.de/30.html

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Brief Summary in Lay Language

Many alcohol dependent patients experience physiological reactions and craving, when there are confronted with specific alcohol related cues like pictures or the odor of alcohol
This increased cue reactivity has been identified as one mechanism underlying the development of alcohol dependence. We could show that cue exposure based extinction training can successfully reduce this reactivity in alcohol patients. During extinction training the patients are confronted with their preferred alcoholic beverage. The alcohol craving should be extinguished or at least reduced in the course of several sessions. In this project, we aim to study the effect of extinction by means of brain imaging methods. We assume that these measures may allow the definition of subgroups that benefit differentially from a cue-exposure based extinction training. This could be helpful for the improvement of the psychotherapeutic treatment of alcohol dependent patients.

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Brief Summary in Scientific Language

The aim of this project is to explore the neurobiological mechanisms underlying the increased cue reactivity often observed in alcohol dependence. Cue reactivity in this context means the response to conditioned stimuli associated with addiction. On a neurobiological level, increased striatal activation triggered by such “cues” can be observed. Increased cue reactivity has been indentified as a risk factor for the occurrence of addictive disorders and relapses in such patients. Cue-exposure-based extinction training (CET), i.e. the confrontation of patients with alcohol cues without the consumption behavior has been described ia an effective treatment in a number of studies. This project will examine whether particular neurobiological characteristics of the patients have an impact on the effectiveness of CET. The theory of extinction learining assumes that extinction occurs through an inhibition of striatal regions via prefrontal projections. Therefore we expect that the extent of functional and structural coupling of prefrontal and striatral brain regions influences the success of CET in alcohol dependent patients. In addition, we want to study whether the reactivity of the striatral regions to non-alcohol-related rewards also has predictive power for the effect of the treatment. Finally, we examine on a subgroup of patients, whether neurofeedback-training can strengthen the effect of extinction training and, if so, to what extent this effect is also modulated by the fronto-striatal connectivity of the patients.

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Organizational Data

  •   DRKS00003388
  •   2011/12/14
  •   [---]*
  •   yes
  •   Approved
  •   2011-303N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   Abstinent alcohol-dependent patients with cue-exposure therapy (CET) (9 therapeutic sessions about 1.5 h)
  •   Abstinent alcohol-dependent patients without cue-exposure therapy (CET)
  •   Healthy controls
  •   Abstinent alcohol-dependent patients with cue-exposure therapy (CET) (9 therapeutic sessions about 1.5 h): additional neurofeedback-training (3 sessions at 1 h each)
  •   Abstinent alcohol-dependent patients without cue-exposure therapy (CET): with neurofeedback-training (3 sessions at 1 h each)
  •   Healthy volunteers to establish the neurofeedback training (1 session about 1h, neurofeedback training in MRI)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Extent of changes of functional and structural connectivity between prefrontal and striatal brain regions caused by the cue-exposure-based extinction training (CET) or neurofeedback as measured by magnetoresonance tomographic methods. Two MRI examinations: Baseline (5 to 21 days after detoxification) and the second three weeks later after the completion of the therapy.

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Secondary Outcome

Abstinence of alcohol-dependent patients 3 months after completion of treatment measured by breath test, blood test and Form 90 (Questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/06/01
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All:
Age: between 18 and 65 years
Visus > 0.8 Landolt (rings),
Appropriate comprehension of the German language,
Written informed consent

Patients:
Alcohol dependent patients according to DSM-IV and ICD-10 criteria will be included after admission to inpatient detoxification and must be abstinent for 5 -21 days when the first assessment takes place.

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Exclusion Criteria

Axis I mental disorders (SCID-I) except (for patients) abuse and dependence of alcohol and nicotine,
neurological disorders,
exclusion criteria for MRT (pace maker, implanted metal or pregnancy)
positive drug screening,
any current psychoactive medication for the last 3 days before study entry,
epilepsy,
suicidal tendencies.

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Addresses

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    • Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Mr.  Prof. Dr. med.  Falk  Kiefer 
    • J5
    • 68159  Mannheim
    • Germany
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    • Abteilung Klinische Psychologie, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Mr.  Prof.Dr.  Peter  Kirsch 
    • J5
    • 68159  Mannheim
    • Germany
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    • Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Mr.  Prof. Dr. med.  Falk  Kiefer 
    • J5
    • 68159  Mannheim
    • Germany
    end of 1:1-Block address scientific-contact
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  • start of 1:1-Block address scientific-contact
    • Abteilung Klinische Psychologie, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Mr.  Prof.Dr.  Peter  Kirsch 
    • J5
    • 68159  Mannheim
    • Germany
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    • Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit, Universität Heidelberg
    • Ms.  Martina  Kirsch 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/01
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Trial Publications, Results and other Documents

  •   Kirsch, M., Gruber, I., Ruf, M., Kiefer, F., & Kirsch, P. (2015). Real-time functional magnetic resonance imaging neurofeedback can reduce striatal cue-reactivity to alcohol stimuli. Addict Biol. doi: 10.1111/adb.12278
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* This entry means the parameter is not applicable or has not been set.