Status:
UNKNOWN
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
Lead Sponsor:
Jens Kuhn
Conditions:
Addiction
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid addiction. The included patien...
Eligibility Criteria
Inclusion
- Age \> 18 years
- 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
- Hospitalization by PsychKG
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01245075
Start Date
January 1 2011
End Date
December 1 2017
Last Update
December 7 2016
Active Locations (1)
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1
University of Cologne
Cologne, Germany, 50924