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The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Primary Purpose

Opiate Addiction

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Suzhou Sceneray® DBS System
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai RuiJin Hospital Psychitric DepartmentRecruiting
  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep brain stimulation

Arm Description

Outcomes

Primary Outcome Measures

Weekly urine tests

Secondary Outcome Measures

Change in 10-point visual analog scale (VAS) craving score for opioid drugs
Change in Hamilton Anxiety Scale
Change in Hamilton Depression Scale-17
Change in SF-36 assessment
Neuropsychological measures（Scores of Iowa gambling task and Model task）

Full Information

First Posted
March 29, 2015
Last Updated
June 28, 2017
Sponsor
Ruijin Hospital
Collaborators
Suzhou Sceneray Medical Co. , Ltd, Shanghai Mental Health Center, Institution of Neuroscience, National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT02440152
Brief Title
The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
Official Title
The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Suzhou Sceneray Medical Co. , Ltd, Shanghai Mental Health Center, Institution of Neuroscience, National Natural Science Foundation of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep brain stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Suzhou Sceneray® DBS System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Weekly urine tests
Time Frame
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary Outcome Measure Information:
Title
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
Title
Change in Hamilton Anxiety Scale
Time Frame
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Title
Change in Hamilton Depression Scale-17
Time Frame
Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Title
Change in SF-36 assessment
Time Frame
Baseline (preoperative), 6 months, 12 month, 24 month
Title
Neuropsychological measures（Scores of Iowa gambling task and Model task）
Time Frame
Baseline (preoperative), Intraoperative,6 months,12month,24month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ChenCheng Zhang, MD
Email
i@cczhang.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Zeljic, MSc
Email
zeljickristina@ion.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai RuiJin Hospital Psychitric Department
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Jin, MD
Email
hyjin603@163.com
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Du, MD
Email
dujiangdou@163.com
First Name & Middle Initial & Last Name & Degree
Min Zhao, MD,PhD
Email
drzhaomin@sh163.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21931318
Citation
Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20.
Results Reference
background
PubMed Identifier
23337942
Citation
Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.
Results Reference
result
PubMed Identifier
22281120
Citation
Valencia-Alfonso CE, Luigjes J, Smolders R, Cohen MX, Levar N, Mazaheri A, van den Munckhof P, Schuurman PR, van den Brink W, Denys D. Effective deep brain stimulation in heroin addiction: a case report with complementary intracranial electroencephalogram. Biol Psychiatry. 2012 Apr 15;71(8):e35-7. doi: 10.1016/j.biopsych.2011.12.013. Epub 2012 Jan 26. No abstract available.
Results Reference
result
PubMed Identifier
21489407
Citation
Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.
Results Reference
result

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The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

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