Addiction
Conditions
Keywords
Opiate dependence, Deep brain stimulation, Nucleus accumbens
Brief summary
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.
Interventions
PROCEDUREDeep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
methadone maintenance treatment
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10) * At least three detoxication-treatments without a long-term period of abstinence has already taken place * Long-term inpatient treatment to support abstinence have occurred * completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal * negative morphine urinalysis and naloxone tests * Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
Exclusion criteria
* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder) * Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator * Current and in the last six months existent paranoid-hallucinated symptomatology * Foreign aggressiveness in the last six months * Stereotactic respectively neurosurgical intervention in the past * Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases) * Serious and instable organic diseases (e.g. instable coronal heart disease) * tested positively for HIV * pregnancy and/or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment retention | 12 months | Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Addiction Severity Index (ASI lite) composite scores | Baseline, 3 month, 6 month and 12month follow-up assessments | — |
| Psychological evaluation | Baseline, 3 month, 6 month and 12month follow-up assessments | The Symptom Checklist - 90 (SCL-90) for evaluating general status, Self-Rating Depression Scale (SDS)for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point. |
| Personality evaluation | Baseline, 3 month, 6 month and 12month follow-up assessments | The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point. |
| Change of participants' craving for opioid drugs | Baseline, 3 month, 6 month and 12month follow-up assessments | The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point. |
| Evaluation of quality of life | Baseline, 3 month, 6 month and 12 month follow-up assessments | The MOS item short from health survey(SF-36) be utilized at each time point. |
| Change in two static positron emission tomography(PET) images study | Baseline and 6month follow-up | \[18F\]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point. |
| Cognitive evaluation | Baseline, 3 month, 6 month and 12month follow-up assessments | The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point. |
Countries
China
Contacts
Primary ContactGuo-dong Gao, M.D.
Backup ContactXue-lian Wang, M.D.
Outcome results
None listed