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Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction (NASA)

This study is currently recruiting participants.
Verified September 2012 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Jens Kuhn, University of Cologne
ClinicalTrials.gov Identifier:
NCT01245075
First received: November 19, 2010
Last updated: September 17, 2012
Last verified: September 2012
History of Changes

November 19, 2010
September 17, 2012
January 2011
June 2013   (final data collection date for primary outcome measure)
Reduction of Levomethadone [ Time Frame: seven month ] [ Designated as safety issue: Yes ]
Reduction of the dosage of the substitute (in detail Levomethadone) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
Same as current
Complete list of historical versions of study NCT01245075 on ClinicalTrials.gov Archive Site
Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs) [ Time Frame: seven month ] [ Designated as safety issue: Yes ]
Drug seeking and goal directed behavior (accessed with EEG) Craving (10-point visual analog scale (VAS)) Psychological components (Anxiety (HAMA); Depression (BDI-II); Quality of life (MSLQ) . Laboratory parameters in the urine (parallel consumption of other drugs)
Same as current
Not Provided
Not Provided
 
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction

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 patients have been treated so far with a substitute in form of methadone.

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.
Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Addiction
  • Other: Deep brain stimulation
    Deep brain stimulation on
  • Other: Placebo
    deep brain stimulation off
  • Active Comparator: Deep Brain Stimulation
    Stimulator setting is ON
    Intervention: Other: Deep brain stimulation
  • Sham Comparator: Placebo
    Stimulator setting is OFF
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact: Volker Sturm, MD ++49221-478-4580 volker.sturm@uk-koeln.de
Contact: Jens Kuhn, MD ++49221-478-4005 jens.kuhn@uk-koeln.de
Germany
 
NCT01245075
10-090
Yes
Jens Kuhn, University of Cologne
Jens Kuhn
Not Provided
Principal Investigator: Volker Sturm, MD University of Cologne
Principal Investigator: Jens Kuhn, MD University of Cologne
University of Cologne
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP