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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01658592
Other study ID # NAc-VC DBS for alcohol addict
Secondary ID
Status Recruiting
Phase N/A
First received July 26, 2012
Last updated August 2, 2012
Start date July 2012
Est. completion date March 2014

Study information

Verified date August 2012
Source Tang-Du Hospital
Contact Gao G Dong, Doctor
Phone +86 29-84777435
Email gguodong@fmmu.edu.cn
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Deep brain stimulation
Stimulator setting is ON
Placebo
Stimulator setting is OFF

Locations

Country Name City State
China Department of neurosurgery, Tangdu Hospital Xi'an Shaanxi

Sponsors (2)

Lead Sponsor Collaborator
Guodong Gao Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Psychological components Addiction severity(ASI); Psychological components (Anxiety (BAI-21 item); Depression (BDI-21 item); Quality of life (WHOQL-Brief); Health condition(SF-36). 7 months Yes
Primary Reduction of Alcohol 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. 7 months Yes
Secondary Craving 10-point visual analog scale (VAS) of craving 7 months Yes
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