Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

April 14, 2014 updated by: Guodong Gao, Tang-Du Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Department of Neurosurgery, Tangdu Hospital
        • Sub-Investigator:
          • Xue-lian Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment retention
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of participants' craving for opioid drugs
Time Frame: 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.
Baseline, 3 month, 6 month and 12month follow-up assessments
Change in Addiction Severity Index (ASI lite) composite scores
Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments
Baseline, 3 month, 6 month and 12month follow-up assessments
Psychological evaluation
Time Frame: 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.
Baseline, 3 month, 6 month and 12month follow-up assessments
Personality evaluation
Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments
The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.
Baseline, 3 month, 6 month and 12month follow-up assessments
Cognitive evaluation
Time Frame: 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.
Baseline, 3 month, 6 month and 12month follow-up assessments
Evaluation of quality of life
Time Frame: 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.
Baseline, 3 month, 6 month and 12 month follow-up assessments
Change in two static positron emission tomography(PET) images study
Time Frame: Baseline and 6month follow-up
[18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.
Baseline and 6month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NACDBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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