Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule for Severe Alcohol Addiction

Addiction Clinical Trial

Official title:

Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01658592
• Other study ID #: NAc-VC DBS for alcohol addict
• 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

• Addiction
• Alcoholism
• Behavior, Addictive

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