Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
NCT ID: NCT01245075
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
10 participants
INTERVENTIONAL
2011-01-31
2017-12-31
Brief Summary
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Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Deep Brain Stimulation
Stimulator setting is ON
Deep brain stimulation
Deep brain stimulation on
Placebo
Stimulator setting is OFF
Placebo
deep brain stimulation off
Interventions
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Deep brain stimulation
Deep brain stimulation on
Placebo
deep brain stimulation off
Eligibility Criteria
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Inclusion Criteria
* Proficiency in the German language
* Long lasting heroin addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
* At least one detoxication-treatment without a long-term period of abstinence has already taken place
* Long-term inpatient treatment to support abstinence have occurred
* Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
* If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
* Substitution treatment with constant dose within the last three months before study inclusion
Exclusion Criteria
* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
* Current and in the last six months existent paranoid-hallucinated symptomatology
* Foreign aggressiveness in the last six months
* Verbal IQ \< 85 (evaluated with the German Mehrfachauswahl-Intelligenz-Test (MWT-A/B))
* Stereotactic respectively neurosurgical intervention in the past
* Neoplastical neurological diseases
* Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and instable organic diseases (e.g. instable coronal heart disease)
* tested positively for HIV
* pregnancy and/or lactation
18 Years
ALL
No
Sponsors
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Jens Kuhn
OTHER
Responsible Party
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Jens Kuhn
Prof. Dr.
Principal Investigators
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Veerle Visser-Vandewalle, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Jens Kuhn, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Locations
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University of Cologne
Cologne, , Germany
Countries
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Central Contacts
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References
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Baldermann JC, Schuller T, Huys D, Becker I, Timmermann L, Jessen F, Visser-Vandewalle V, Kuhn J. Deep Brain Stimulation for Tourette-Syndrome: A Systematic Review and Meta-Analysis. Brain Stimul. 2016 Mar-Apr;9(2):296-304. doi: 10.1016/j.brs.2015.11.005. Epub 2015 Dec 29.
Other Identifiers
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10-090
Identifier Type: -
Identifier Source: org_study_id