Opiate Addiction
Conditions
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.
Interventions
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).
Sponsors
Suzhou Sceneray Medical Co. , Ltd
Shanghai Mental Health Center
Institution of Neuroscience
National Natural Science Foundation of China
Ruijin Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly urine tests | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 Hamilton Anxiety Scale | 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 |
Countries
China
Contacts
Primary ContactChenCheng Zhang, MD
Backup ContactKristina Zeljic, MSc
Outcome results
None listed