search
Back to results

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

Primary Purpose

Addiction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Suzhou Sceneray® DBS System
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring Opiate dependence, Deep brain stimulation, Nucleus accumbens

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years old < Age < 50 years old

  • Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)

    1. History of opiates abuse no less than 3 years
    2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
    3. completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
  • Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)

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
  • Abuse of other type of drugs
  • severe cognitive impairments
  • Enrollment in other clinical trials
  • 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
  • Severe disorders for coagulation and liver function
  • Epilepsy or other severe brain trauma or neurological impairments

Sites / Locations

  • National Institute on Drug Dependence, Peking UniversityRecruiting
  • Nanfang Hospital Southern Medical UniversityRecruiting
  • Department of neurosurgery, Tangdu HospitalRecruiting
  • Ruijin HospitalRecruiting
  • West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Postoperative immediate Deep brain stimulation

Postoperative delayed Deep brain stimulation

Arm Description

The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.

The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.

Outcomes

Primary Outcome Measures

The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse

Secondary Outcome Measures

The total days of abstinence for participants
The total days of abstinence for participants
The longest duration for sustained abstinence for participants
The longest duration for sustained abstinence for participants
Visual analog scale (VAS) craving score for opioid drugs
Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving
Body weight for participants
Body weight for participants
Hamilton Depression Scale（HAMD-17)
17 items,Total scores<7: normal;7<Total scores<17:possible depression;17<Total scores<24:definite depression;Total score>24: severe depression
Scaling for Opiate withdrawal symptoms
There were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms.
The evaluation on MATRICS-test
Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants
The rate of positive urine test results
times of positive urine test/ total times of urine test
Hamilton Anxiety Scale (HAMA)
14 items, Total scores<6: normal;7<Total scores<14:possible anxiety;14<Total scores<21:definite anxiety;Total score>21: severe anxiety
Pittsburgh sleep quality index(PSQI)
Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality
Fagerstrom Test Nicotine Dependence assessment (FTND)
Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence
Social Disability Screening Schedule (SDSS)
Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability
Activity of Daily Living Scale (ADL)
Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores <14, normal; total score >14, ADL dysfunction
36-Item Short Form Health Survey (SF-36)
Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.

Full Information

First Posted
January 17, 2018
Last Updated
January 31, 2018
Sponsor
Tang-Du Hospital
Collaborators
National Institute on Drug Dependence, Peking University, Ruijin Hospital, West China Hospital, Nanfang Hospital, Southern Medical University, Peking University First Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03424616
Brief Title
Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention
Official Title
Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2018 (Anticipated)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
Collaborators
National Institute on Drug Dependence, Peking University, Ruijin Hospital, West China Hospital, Nanfang Hospital, Southern Medical University, Peking University First Hospital

4. Oversight

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

5. Study Description

Brief Summary
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
Opiate dependence, Deep brain stimulation, Nucleus accumbens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stagger-on design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postoperative immediate Deep brain stimulation
Arm Type
Experimental
Arm Description
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
Arm Title
Postoperative delayed Deep brain stimulation
Arm Type
Sham Comparator
Arm Description
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.
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.
Primary Outcome Measure Information:
Title
The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
Description
If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse
Time Frame
At 25 weeks after DBS stimulation on
Secondary Outcome Measure Information:
Title
The total days of abstinence for participants
Description
The total days of abstinence for participants
Time Frame
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
The longest duration for sustained abstinence for participants
Description
The longest duration for sustained abstinence for participants
Time Frame
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Visual analog scale (VAS) craving score for opioid drugs
Description
Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Body weight for participants
Description
Body weight for participants
Time Frame
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Hamilton Depression Scale（HAMD-17)
Description
17 items,Total scores<7: normal;7<Total scores<17:possible depression;17<Total scores<24:definite depression;Total score>24: severe depression
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Scaling for Opiate withdrawal symptoms
Description
There were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms.
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
The evaluation on MATRICS-test
Description
Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
The rate of positive urine test results
Description
times of positive urine test/ total times of urine test
Time Frame
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Hamilton Anxiety Scale (HAMA)
Description
14 items, Total scores<6: normal;7<Total scores<14:possible anxiety;14<Total scores<21:definite anxiety;Total score>21: severe anxiety
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Pittsburgh sleep quality index(PSQI)
Description
Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Fagerstrom Test Nicotine Dependence assessment (FTND)
Description
Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Social Disability Screening Schedule (SDSS)
Description
Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
Activity of Daily Living Scale (ADL)
Description
Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores <14, normal; total score >14, ADL dysfunction
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Title
36-Item Short Form Health Survey (SF-36)
Description
Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.
Time Frame
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old < Age < 50 years old Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5) History of opiates abuse no less than 3 years Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine) Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment) 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 Abuse of other type of drugs severe cognitive impairments Enrollment in other clinical trials 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 Severe disorders for coagulation and liver function Epilepsy or other severe brain trauma or neurological impairments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guodong Gao, M.D.
Phone
+86 29 84717556
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Lu, M.D.
Phone
+86 13801027748
Email
linlu@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guodong Gao, M.D.
Organizational Affiliation
Department of neurosurgery, Tangdu Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lin Lu, M.D.
Organizational Affiliation
National Institute on Drug Dependence, Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute on Drug Dependence, Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Lu, M.D.
Phone
+86 13801027748
Email
linlu@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jie Shi, M.D.
Phone
+86 13910710407
First Name & Middle Initial & Last Name & Degree
Lin Lu, M.D.
Facility Name
Nanfang Hospital Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaijun Yang, M.D.
Phone
+86 13380082493
First Name & Middle Initial & Last Name & Degree
Kaijun Yang, M.D.
Facility Name
Department of neurosurgery, Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guodong Gao, M.D.
Phone
+86 29 84717556
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xuelian Wang, M.D.
Phone
+86 29 84777284
Email
wxlian@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Guodong Gao, M.D.
First Name & Middle Initial & Last Name & Degree
Xuelian Wang, M.D.
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, M.D.
Phone
+86 13817777401
Email
bominsun@sh163a.sta.net.cn
First Name & Middle Initial & Last Name & Degree
Bomin Sun, M.D.
Facility Name
West China Hospital
City
Chengdu
State/Province
Si Chuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, M.D.
Phone
+86 13808170699
First Name & Middle Initial & Last Name & Degree
Wei Wang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
30765398
Citation
Qu L, Ge S, Li N, Wang W, Yang K, Wu P, Wang X, Shi J. Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study. BMJ Open. 2019 Feb 13;9(2):e023516. doi: 10.1136/bmjopen-2018-023516.
Results Reference
derived

Learn more about this trial

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

We'll reach out to this number within 24 hrs