Addiction
Conditions
Keywords
Alcohol Addiction;, Deep Brain Stimulation;, Nucleus Accumbens;, Ventral Anterior Internal capsule;
Brief summary
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. The included patients have been treated so far with drugs that inhibits alcohol, or psychological behavior training. Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
Detailed description
The nucleus accumbens (NAc) is considered associating with addiction. The ventral anterior internal capsule(VC) is proved a effective target to obsessive compulsive disorder(OCD). Like other addiction behaviors most alcohol addicts contain obsessive compulsive symptom. We explored an operation method, that is, in the Leksell stereotactic positioning system take VC as the point of entry, take NAc as the point of target, then make sure that the distance between entry and target points are included in the four contacts of electrode of DBS. When stimulator is ON the investigators can adjust parameters so that the coverage of electrode contains both Vc and NAc. The investigators suppose that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
Interventions
OTHERDeep brain stimulation
Stimulator setting is ON
OTHERPlacebo
Stimulator setting is OFF
Sponsors
Tang-Du Hospital
Guodong Gao
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Long lasting alcohol addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10) * At least one detoxication-treatment without a long-term period of abstinence has already taken place * Long-term inpatient treatment to support abstinence have occurred * Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance) * If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
Exclusion criteria
* Hospitalization for psychotic symptoms * Clinical relevant psychiatric comorbidity (such as schizophrenic psychoses, bipolar affective diseases, severe personality disorder, and so on. And diagnosed by criteria according to DSM-IV,ICD-10) * 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 * Verbal IQ \< 85 (evaluated with the Wechsler Adult Intelligence Scale- Chinese Revised (WAIS-CR) * Stereotactic respectively neurosurgical intervention in the past * Other neurological diseases * 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 |
|---|---|---|
| Reduction of Alcohol | 7 months | Reduction of the dosage of alcohol(all kinds of liquor were converted into pure alcohol) comparing baseline and the particular ward rounds during and at the end of the crossover-design. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Craving | 7 months | 10-point visual analog scale (VAS) of craving |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychological components | 7 months | Addiction severity(ASI); Psychological components (Anxiety (BAI-21 item); Depression (BDI-21 item); Quality of life (WHOQL-Brief); Health condition(SF-36). |
Countries
China
Contacts
Primary ContactGao G Dong, Doctor
Backup ContactWang X Lian, Doctor
Outcome results
None listed