Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

Not Applicable

• Conditions: Addiction
• Interventions: Procedure: Deep brain stimulation; Other: methadone maintenance treatment

• Registration Number: NCT01274988
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Study Start: 2011-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-16
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep brain stimulation	Continuous deep brain stimulation of bilateral nucleus accumbens
Standard Control	methadone maintenance treatment	methadone maintenance treatment

Primary Outcome Measures

Name	Time	Method
Treatment retention	12 months	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of quality of life	Baseline, 3 month, 6 month and 12 month follow-up assessments	The MOS item short from health survey(SF-36) be utilized at each time point.
Change in two static positron emission tomography(PET) images study	Baseline and 6month follow-up	\[18F\]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.
Change of participants' craving for opioid drugs	Baseline, 3 month, 6 month and 12month follow-up assessments	The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point.
Change in Addiction Severity Index (ASI lite) composite scores	Baseline, 3 month, 6 month and 12month follow-up assessments
Psychological evaluation	Baseline, 3 month, 6 month and 12month follow-up assessments	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.
Personality evaluation	Baseline, 3 month, 6 month and 12month follow-up assessments	The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.
Cognitive evaluation	Baseline, 3 month, 6 month and 12month follow-up assessments	The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.

Trial Locations

Locations (1)

Department of neurosurgery, Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China