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

Addiction Clinical Trial

— NASA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01245075
• Other study ID #: 10-090
• Status: Recruiting
• Phase: Phase 0
• First received: November 19, 2010
• Last updated: December 6, 2016
• Start date: January 2011
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: University of Cologne
• Contact: Jens Kuhn, MD
• Phone: ++49221-478-4005
• Email: jens.kuhn[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

Other:
• Deep brain stimulation
Deep brain stimulation on
• Placebo
deep brain stimulation off

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Jens Kuhn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	seven month	Yes