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

Primary Purpose

Addiction

Status
Unknown status
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Deep brain stimulation
Placebo
Sponsored by
Jens Kuhn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CologneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Deep Brain Stimulation

Placebo

Arm Description

Stimulator setting is ON

Stimulator setting is OFF

Outcomes

Primary Outcome Measures

Reduction of Levomethadone
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)
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)

Full Information

First Posted
November 19, 2010
Last Updated
December 6, 2016
Sponsor
Jens Kuhn
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1. Study Identification

Unique Protocol Identification Number
NCT01245075
Brief Title
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
Acronym
NASA
Official Title
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Kuhn

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Active Comparator
Arm Description
Stimulator setting is ON
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Stimulator setting is OFF
Intervention Type
Other
Intervention Name(s)
Deep brain stimulation
Intervention Description
Deep brain stimulation on
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
deep brain stimulation off
Primary Outcome Measure Information:
Title
Reduction of Levomethadone
Description
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.
Time Frame
seven month
Secondary Outcome Measure Information:
Title
Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs)
Description
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)
Time Frame
seven month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Kuhn, MD
Phone
++49221-478-4005
Email
jens.kuhn@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Veerle Visser-Vandewalle, MD
Phone
++49221-478-82792
Email
veerle.visser-vandewalle@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veerle Visser-Vandewalle, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Kuhn, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
26827109
Citation
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.
Results Reference
derived

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

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