NCT01658592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

1.7 years

First QC Date

July 26, 2012

Last Update Submit

August 2, 2012

Conditions

Addiction

Keywords

Alcohol Addiction;Deep Brain Stimulation;Nucleus Accumbens;Ventral Anterior Internal capsule;

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Craving

    7 months

Other Outcomes (1)

  • Psychological components

    7 months

Study Arms (4)

NAC-VC Deep Brain Stimulation

EXPERIMENTAL

The contractors located in NAc and VC are ON at the same time

Other: Deep brain stimulationOther: Placebo

Placebo A

SHAM COMPARATOR

Stimulator setting is OFF

Other: Deep brain stimulationOther: Placebo

Placebo B

EXPERIMENTAL

The contractor located in NAc is on

Other: Deep brain stimulationOther: Placebo

Placebo C

EXPERIMENTAL

The contactor located in VC is on

Other: Deep brain stimulationOther: Placebo

Interventions

Deep brain stimulationOTHER

Stimulator setting is ON

NAC-VC Deep Brain StimulationPlacebo APlacebo BPlacebo C
PlaceboOTHER

Stimulator setting is OFF

NAC-VC Deep Brain StimulationPlacebo APlacebo BPlacebo C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurosurgery, Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Behavior, AddictiveAlcoholism

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Gao G Dong, Doctor

    Department of neurosurgery, Tangdu Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao G Dong, Doctor

CONTACT

+86 29-84777435gguodong@fmmu.edu.cn

Wang X Lian, Doctor

CONTACT

+86 29-84777284tdwxlian@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurosurgery Department

Study Record Dates

First Submitted

July 26, 2012

First Posted

August 7, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

CN(1)