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

October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 310000
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Bomin Sun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deep Brain Stimulation
Stimulator is ON
Device: Deep brain stimulation：PINS Stimulation System
Other Names:
  • Non-rechargeable Implanted device
Sham Comparator: Placebo
Stimulator is OFF
Device: Deep brain stimulation：PINS Stimulation System
Other Names:
  • Non-rechargeable Implanted device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Addiction

Clinical Trials on Deep brain stimulation：PINS Stimulation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe