Clincosm LogoSign in Get a demo

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

Sponsor
Beijing Pins Medical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02282072
Collaborator
Beijing Tiantan Hospital (Other)
20
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep brain stimulation：PINS Stimulation System
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Schedule for the Assessment of Negative Symptoms (SANS) [6 month]

    Secondary Outcome Measures

    1. Chronic Hunger Scale [6 month]

    2. Beck Depression Inventory [6 month]

    3. Buss & Perry Aggression Questionnaire [6 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 310000

    Sponsors and Collaborators

    • Beijing Pins Medical Co., Ltd
    • Beijing Tiantan Hospital

    Investigators

    • Study Chair: Li Luming, PhD, Tsinghua University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Pins Medical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT02282072
    Other Study ID Numbers:
    • PINS-003
    First Posted:
    Nov 4, 2014
    Last Update Posted:
    Oct 14, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Opioid-Related Disorders
    Behavior, Addictive

    Study Results

    No Results Posted as of Oct 14, 2016