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Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

Primary Purpose

Addiction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation
methadone maintenance treatment
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of neurosurgery, Tangdu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deep Brain Stimulation

Standard Control

Arm Description

Continuous deep brain stimulation of bilateral nucleus accumbens

methadone maintenance treatment

Outcomes

Primary Outcome Measures

Treatment retention
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

Change of participants' craving for opioid drugs
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
Psychological evaluation
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
The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.
Cognitive evaluation
The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.
Evaluation of quality of life
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
[18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.

Full Information

First Posted
January 11, 2011
Last Updated
April 14, 2014
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01274988
Brief Title
Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse
Official Title
Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital

4. Oversight

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, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent 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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Continuous deep brain stimulation of bilateral nucleus accumbens
Arm Title
Standard Control
Arm Type
Active Comparator
Arm Description
methadone maintenance treatment
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation
Intervention Description
Deep brain stimulation of bilateral nucleus accumbens
Intervention Type
Other
Intervention Name(s)
methadone maintenance treatment
Intervention Description
methadone maintenance treatment
Primary Outcome Measure Information:
Title
Treatment retention
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of participants' craving for opioid drugs
Description
The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point.
Time Frame
Baseline, 3 month, 6 month and 12month follow-up assessments
Title
Change in Addiction Severity Index (ASI lite) composite scores
Time Frame
Baseline, 3 month, 6 month and 12month follow-up assessments
Title
Psychological evaluation
Description
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.
Time Frame
Baseline, 3 month, 6 month and 12month follow-up assessments
Title
Personality evaluation
Description
The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.
Time Frame
Baseline, 3 month, 6 month and 12month follow-up assessments
Title
Cognitive evaluation
Description
The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.
Time Frame
Baseline, 3 month, 6 month and 12month follow-up assessments
Title
Evaluation of quality of life
Description
The MOS item short from health survey(SF-36) be utilized at each time point.
Time Frame
Baseline, 3 month, 6 month and 12 month follow-up assessments
Title
Change in two static positron emission tomography(PET) images study
Description
[18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.
Time Frame
Baseline and 6month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-dong Gao, M.D.
Phone
+86 29 84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xue-lian Wang, M.D.
Phone
+86 29 84777284
Email
wxlian@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-dong Gao, M.D.
Organizational Affiliation
Department of neurosurgery, Tangdu Hospital
Official's Role
Principal Investigator
Facility Information:
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
Guo-dong Gao, M.D.
Phone
+86 29 84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xue-lian Wang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
30245163
Citation
Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14.
Results Reference
derived

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Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

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