PINS Stimulator System for Deep Brain Stimulation of the... | NCT02282072

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

NCT02282072

Sponsor

Beijing Pins Medical Co., Ltd

Status

Unknown status

Last Update Posted

Oct 14, 2016Estimated

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

Opioid Addiction

Interventions

Deep brain stimulation：PINS Stimulation System

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Sep 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Nov 3, 2014

First Posted Date

Nov 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Name	Class
Beijing Tiantan Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deep Brain Stimulation	Active Comparator	Stimulator is ON	Device: Deep brain stimulation：PINS Stimulation System
Placebo	Sham Comparator	Stimulator is OFF	Device: Deep brain stimulation：PINS Stimulation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep brain stimulation：PINS Stimulation System	Device		Deep Brain Stimulation Placebo	Non-rechargeable Implanted device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Schedule for the Assessment of Negative Symptoms (SANS)		6 month

Secondary Outcomes

Measure	Description	Time Frame
Chronic Hunger Scale		6 month
Beck Depression Inventory		6 month
Buss & Perry Aggression Questionnaire

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jia Fumin, PhD	Contact	+86 010-59361265		pins_medical@163.com

Overall Officials

Name	Affiliation	Role
Li Luming, PhD	Tsinghua University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital, Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality	310000	China

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided