Status:
UNKNOWN
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Opioid Addiction
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02282072
Start Date
December 1 2016
End Date
December 1 2018
Last Update
October 14 2016
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 310000