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

Opioid Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02282072
• Other study ID #: PINS-003
• 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

• Behavior, Addictive
• Opioid Addiction

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