NCT01245075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

6.4 years

First QC Date

November 19, 2010

Last Update Submit

December 6, 2016

Conditions

Addiction

Outcome Measures

Primary Outcomes (1)

  • 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.

    seven month

Secondary Outcomes (1)

  • Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs)

    seven month

Study Arms (2)

Deep Brain Stimulation

ACTIVE COMPARATOR

Stimulator setting is ON

Other: Deep brain stimulation

Placebo

SHAM COMPARATOR

Stimulator setting is OFF

Other: Placebo

Interventions

Deep brain stimulationOTHER

Deep brain stimulation on

Deep Brain Stimulation
PlaceboOTHER

deep brain stimulation off

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, 50924, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26827109DERIVED

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Veerle Visser-Vandewalle, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

  • Jens Kuhn, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Kuhn, MD

CONTACT

++49221-478-4005jens.kuhn@uk-koeln.de

Veerle Visser-Vandewalle, MD

CONTACT

++49221-478-82792veerle.visser-vandewalle@uk-koeln.de

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

DE(1)