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

Early Phase 1

• Conditions: Addiction
• Interventions: Other: Deep brain stimulation; Other: Placebo

• Registration Number: NCT01245075
• Lead Sponsor: Jens Kuhn

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Study Start: 2011-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep brain stimulation	Stimulator setting is ON
Placebo	Placebo	Stimulator setting is OFF

Primary Outcome Measures

Name	Time	Method
Reduction of Levomethadone	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, Germany