The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

June 28, 2017 updated by: Bomin Sun, Ruijin Hospital

The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .

The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai RuiJin Hospital Psychitric Department
        • Contact:

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Proficiency in Mandarin language
  • Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
  • Duration longer than 6 months
  • A lack of response to long-term treatment
  • Capacity to provide informed consent (understanding of the study purpose and methods)
  • Substitution methadone treatment at a constant dose within three months prior to inclusion.

Exclusion Criteria:

  • Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
  • Past stereotactic neurosurgical intervention
  • Neurological disease (Abnormal PET-CT, MRI, EEG)
  • Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
  • Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
  • Serious and unstable organic diseases (e.g. unstable coronal heart disease)
  • HIV positive
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep brain stimulation
Device: Suzhou Sceneray® DBS System
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weekly urine tests
Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in 10-point visual analog scale (VAS) craving score for opioid drugs
Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in Hamilton Anxiety Scale
Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in Hamilton Depression Scale-17
Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in SF-36 assessment
Time Frame: Baseline (preoperative), 6 months, 12 month, 24 month
Baseline (preoperative), 6 months, 12 month, 24 month
Neuropsychological measures（Scores of Iowa gambling task and Model task）
Time Frame: Baseline (preoperative), Intraoperative,6 months,12month,24month
Baseline (preoperative), Intraoperative,6 months,12month,24month

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Collaborators

National Natural Science Foundation of China
Shanghai Mental Health Center
Suzhou Sceneray Medical Co. , Ltd
Institution of Neuroscience

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 (Actual)

February 1, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 29, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Opiate Addiction

Clinical Trials on Suzhou Sceneray® DBS System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe