Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

Study Overview
=================
Brief Summary
-----------------
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.

Official Title
-----------------
Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts

Conditions
-----------------
Addiction

Intervention / Treatment
-----------------
* Procedure: Deep brain stimulation
* Other: methadone maintenance treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10) At least three detoxication-treatments without a long-term period of abstinence has already taken place Long-term inpatient treatment to support abstinence have occurred completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal negative morphine urinalysis and naloxone tests Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance) Exclusion Criteria: 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 Stereotactic respectively neurosurgical intervention in the past 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Continuous deep brain stimulation of bilateral nucleus accumbens | Procedure: Deep brain stimulation<br>* Deep brain stimulation of bilateral nucleus accumbens<br>|
| Active Comparator: Standard Control<br>methadone maintenance treatment | Other: methadone maintenance treatment<br>* methadone maintenance treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention | Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of participants' craving for opioid drugs | The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments | 
| Change in Addiction Severity Index (ASI lite) composite scores |  | Baseline, 3 month, 6 month and 12month follow-up assessments | 
| Psychological evaluation | The Symptom Checklist - 90 (SCL-90) for evaluating general status, Self-Rating Depression Scale (SDS)for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments | 
| Personality evaluation | The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments | 
| Cognitive evaluation | The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments | 
| Evaluation of quality of life | The MOS item short from health survey(SF-36) be utilized at each time point. | Baseline, 3 month, 6 month and 12 month follow-up assessments | 
| Change in two static positron emission tomography(PET) images study | [18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point. | Baseline and 6month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opiate dependence, Deep brain stimulation, Nucleus accumbens