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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. (see Contacts and Locations)
Verified December 2016 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: December 6, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention Phase
Addiction
Other: Deep brain stimulation
Other: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 10
Study Start Date: January 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Deep Brain Stimulation
Stimulator setting is ON
Other: Deep brain stimulation
Deep brain stimulation on
Sham Comparator: Placebo
Stimulator setting is OFF
Other: Placebo
deep brain stimulation off

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245075

Contacts
Contact: Jens Kuhn, MD ++49221-478-4005 jens.kuhn@uk-koeln.de
Contact: Veerle Visser-Vandewalle, MD ++49221-478-82792 veerle.visser-vandewalle@uk-koeln.de

Locations
Germany
University of Cologne Recruiting
Cologne, Germany, 50924
Sponsors and Collaborators
Jens Kuhn
Investigators
Principal Investigator: Veerle Visser-Vandewalle, MD University of Cologne
Principal Investigator: Jens Kuhn, MD University of Cologne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Kuhn, Prof. Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT01245075     History of Changes
Other Study ID Numbers: 10-090 
Study First Received: November 19, 2010
Last Updated: December 6, 2016
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on December 08, 2016