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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02282072
Other study ID # PINS-003
Secondary ID
Status Not yet recruiting
Phase Phase 0
First received September 26, 2014
Last updated October 13, 2016
Start date December 2016
Est. completion date December 2018

Study information

Verified date August 2016
Source Beijing Pins Medical Co., Ltd
Contact Jia Fumin, PhD
Phone +86 010-59361265
Email pins_medical@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Deep brain stimulation:PINS Stimulation System


Locations

Country Name City State
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Beijing Pins Medical Co., Ltd Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Schedule for the Assessment of Negative Symptoms (SANS) 6 month Yes
Secondary Chronic Hunger Scale 6 month Yes
Secondary Beck Depression Inventory 6 month Yes
Secondary Buss & Perry Aggression Questionnaire 6 month Yes
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