Clinical Trial: Deep Brain Stimulation for Refractory Alcoholism

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Pilot Study of Deep Brain Stimulation (DBS) for Refractory Alcoholism

Brief Summary:

Background:

- Current treatments for alcoholism have limited success. More than half of people with alcoholism return to uncontrolled drinking even after treatment or self-help programs. One possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s disease, but not for treating alcoholism. Researchers want to study whether DBS can be used to treat chronic alcoholism.

Objectives:

- To see if deep brain stimulation is helpful and safe for people who have chronic alcoholism.

Eligibility:

• Individuals between 21 and 60 years of age who have been diagnosed with chronic alcoholism.
• Participants must have tried for more than 10 years to stop drinking alcohol, and have failed multiple treatment and self-help programs. They may not have any other current substance abuse or dependence problem (except alcohol and nicotine).

Design:

• Participants will start the study by entering a separate alcohol detoxification study at the National Institutes of Health. They will be monitored during this study with blood tests and brain scans.
• Participants will have 2 weeks of baseline tests. They will include physical exams and blood and urine tests. They will also include tests of thinking and memory, and questions about current moods.
• Objective

  The purpose of this pilot clinical study is to test the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens, ventral striatum and ventral capsule in patients with treatment-resistant alcoholism and to provide critical information for planning subsequent clinical trials, including additional experience with the safety of this procedure.

  Study Population

  Ten patients 21 to 60 years of age with severe, treatment-resistant alcoholism will be enrolled in this study.

  Design

  This study is a randomized, sham-controlled trial with open-label extension exploring the use of DBS of the nucleus accumbens, ventral striatum, and ventral capsule in ten healthy alcohol dependent men and women who have failed repeated alcoholism treatments.

  Neurosurgical implantation of the DBS in the nucleus accumbens, ventral striatum and ventral capsule will be performed. Following surgery but prior to initiation of the titration phase, baseline cognitive and behavioral testing will be performed. Approximately four weeks following placement of the electrodes, a randomized, sham-controlled trial with an open-label extension will be instituted whereby participants will be randomized and blinded to undergo either titration for two weeks followed by 24 weeks with the DBS system ON, or titration followed by 24 weeks with the DBS system OFF.

  After 24 weeks with DBS ON or OFF, the open-label extension phase will occur. All participants will be readmitted to the hospital for the second two-week titration period. The cognitive and behavioral assessments performed at baseline will be
  Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
  

  Current Primary Outcome: Test safety of DBS of the nucleus accumbens, ventral striatum and ventral capsule in patients with treatment-resistant alcoholism. [ Time Frame: 2 years ]
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: February 22, 2013
  Date Started: November 30, 2012
  Date Completion:
  Last Updated: April 19, 2017
  Last Verified: November 13, 2015