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

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Opioid Addiction

Treatments: Device: Deep brain stimulation：PINS Stimulation System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02282072

PINS-003

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Deep Brain Stimulation

Active Comparator group

Description:

Stimulator is ON

Treatment:

Device: Deep brain stimulation：PINS Stimulation System

Placebo

Sham Comparator group

Description:

Stimulator is OFF

Treatment:

Device: Deep brain stimulation：PINS Stimulation System