PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
NCT ID: NCT02282072
Last Updated: 2016-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2016-12-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Deep Brain Stimulation
Stimulator is ON
Deep brain stimulation：PINS Stimulation System
Placebo
Stimulator is OFF
Deep brain stimulation：PINS Stimulation System
Interventions
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Deep brain stimulation：PINS Stimulation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Li Luming, PhD
Role: STUDY_CHAIR
Tsinghua University
Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Bomin Sun, MD
Role: primary
Other Identifiers
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PINS-003
Identifier Type: -
Identifier Source: org_study_id
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