Opioid Addiction
Conditions
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.
Interventions
DEVICEDeep brain stimulation：PINS Stimulation System
Sponsors
Beijing Tiantan Hospital
Beijing Pins Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schedule for the Assessment of Negative Symptoms (SANS) | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Chronic Hunger Scale | 6 month |
| Beck Depression Inventory | 6 month |
| Buss & Perry Aggression Questionnaire | 6 month |
Countries
China
Contacts
Primary ContactJia Fumin, PhD
Outcome results
None listed