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

Early Phase 1

• Conditions: Opioid Addiction
• Interventions: Device: Deep brain stimulation：PINS Stimulation System

• Registration Number: NCT02282072
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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 available

Study Timeline

• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep brain stimulation：PINS Stimulation System	Stimulator is ON
Placebo	Deep brain stimulation：PINS Stimulation System	Stimulator is OFF

Primary Outcome Measures

Name	Time	Method
Schedule for the Assessment of Negative Symptoms (SANS)	6 month

Secondary Outcome Measures

Name	Time	Method
Chronic Hunger Scale	6 month
Beck Depression Inventory	6 month
Buss & Perry Aggression Questionnaire	6 month

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China