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

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.

Study Overview

• Status: Unknown
• Conditions: Addiction
• Intervention / Treatment: Other: Deep brain stimulation; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50924
    • Recruiting
    • University of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Placebo; Stimulator setting is OFF	Other: Placebo; deep brain stimulation off
Active Comparator: Deep Brain Stimulation; Stimulator setting is ON	Other: Deep brain stimulation; Deep brain stimulation on

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jens Kuhn
• Investigators: Principal Investigator: Jens Kuhn, MD, University of Cologne; Principal Investigator: Veerle Visser-Vandewalle, MD, University of Cologne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 19, 2010
• First Posted (Estimate): November 22, 2010

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Opioid-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: 10-090