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

Jens Kuhn1 site in 1 country10 target enrollmentJanuary 2011

ConditionsAddiction

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Addiction
Sponsor: Jens Kuhn
Enrollment: 10
Locations: 1
Primary Endpoint: Reduction of Levomethadone
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

December 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Jens Kuhn

Responsible Party

Sponsor Investigator

Principal Investigator

Jens Kuhn

Prof. Dr.

University of Cologne

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)

Outcomes

Primary Outcomes

Reduction of Levomethadone

Time Frame: seven month

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 Outcomes

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