The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
Phase 2
- Conditions
- Opiate Addiction
- Interventions
- Device: Suzhou Sceneray® DBS System
- Registration Number
- NCT02440152
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .
The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Proficiency in Mandarin language
- Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Duration longer than 6 months
- A lack of response to long-term treatment
- Capacity to provide informed consent (understanding of the study purpose and methods)
- Substitution methadone treatment at a constant dose within three months prior to inclusion.
Exclusion Criteria
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
- Past stereotactic neurosurgical intervention
- Neurological disease (Abnormal PET-CT, MRI, EEG)
- Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
- Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- Serious and unstable organic diseases (e.g. unstable coronal heart disease)
- HIV positive
- Pregnancy and/or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Deep brain stimulation Suzhou Sceneray® DBS System -
- Primary Outcome Measures
Name Time Method Weekly urine tests Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
- Secondary Outcome Measures
Name Time Method Change in Hamilton Anxiety Scale Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months Change in Hamilton Depression Scale-17 Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months Change in 10-point visual analog scale (VAS) craving score for opioid drugs Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months Change in SF-36 assessment Baseline (preoperative), 6 months, 12 month, 24 month Neuropsychological measures（Scores of Iowa gambling task and Model task） Baseline (preoperative), Intraoperative,6 months,12month,24month
Trial Locations
- Locations (2)
Shanghai RuiJin Hospital Psychitric Department
🇨🇳Shanghai, Shanghai, China
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China