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PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

Primary Purpose

Opioid Addiction

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation：PINS Stimulation System
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 years old.
  2. In accordance with the diagnostic standards of DSM-IV & ICD-10 for addicted and DSM-IV for abstinence.
  3. Qualitative urine detection for opioids showing positive result.
  4. Cleared for 8 to 36 hours after their last drug taking.
  5. Fully understood and signed on informed consent.

Exclusion Criteria:

  1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
  2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
  3. Patients with serious infectious disease.
  4. Patients with history of serious neurological or psychiatrical diseases.
  5. Person with history of HIV infection or serious malnutrition.
  6. Dependent upon and addicted to multiple drugs.
  7. Attended some other drug trials within one month.

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Deep Brain Stimulation

Placebo

Arm Description

Stimulator is ON

Stimulator is OFF

Outcomes

Primary Outcome Measures

Schedule for the Assessment of Negative Symptoms (SANS)

Secondary Outcome Measures

Chronic Hunger Scale
Beck Depression Inventory
Buss & Perry Aggression Questionnaire

Full Information

First Posted
September 26, 2014
Last Updated
October 13, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02282072
Brief Title
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
Official Title
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Active Comparator
Arm Description
Stimulator is ON
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Stimulator is OFF
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation：PINS Stimulation System
Other Intervention Name(s)
Non-rechargeable Implanted device
Primary Outcome Measure Information:
Title
Schedule for the Assessment of Negative Symptoms (SANS)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Chronic Hunger Scale
Time Frame
6 month
Title
Beck Depression Inventory
Time Frame
6 month
Title
Buss & Perry Aggression Questionnaire
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old. In accordance with the diagnostic standards of DSM-IV & ICD-10 for addicted and DSM-IV for abstinence. Qualitative urine detection for opioids showing positive result. Cleared for 8 to 36 hours after their last drug taking. Fully understood and signed on informed consent. Exclusion Criteria: Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems. Patients with serious infectious disease. Patients with history of serious neurological or psychiatrical diseases. Person with history of HIV infection or serious malnutrition. Dependent upon and addicted to multiple drugs. Attended some other drug trials within one month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fumin, PhD
Phone
+86 010-59361265
Email
pins_medical@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Luming, PhD
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD

12. IPD Sharing Statement

Learn more about this trial

PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

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