Deep Brain Stimulation for Refractory Alcoholism

Alcoholism Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

• Participants will have surgery to insert the DBS device. Electrodes will be placed in the brain and a battery pack will be placed in the chest. Participants will recover from the surgery and continue the alcohol detoxification program.

• About 4 weeks after surgery, participants will be separated into two groups. For one group, the DBS device will be turned on with electrical stimulation and participants will be monitored for an additional two weeks in the hospital to find the right setting for the device. For the second group, participants will receive mock stimulation, but no real electrical DBS, and will also be monitored for an additional two weeks in the hospital.

• Participants will return home for 24 weeks. During this time they will have frequent study visits to look at the DBS device. These visits will include questions about mood and memory, as well as imaging studies.

• All participants will return for an additional two week inpatient stay in the hospital. Those participant who had initially received mock stimulation will now have their devices turned on with real electrical stimulation and will be monitored for the two weeks to find the right setting for the device. Those participants who had initially received real stimulation will continue to receive stimulation while being monitored for the two weeks.

• Participants will return home for another 24. All participants at this point will have actual electrical DBS. Participants will continue to have frequent study visits for up to a year to look at the DBS device. These visits will also include questions about mood levels and alcohol cravings.

Clinical Trial Description

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 repeated. Following the inpatient titration phase, they will be discharged from the hospital and followed in the outpatient clinic for 24 weeks with the DBS ON. Cognitive and behavioral assessments which were performed at baseline will be repeated at the end of this 24-week period. Participants will be followed monthly after this time for 9 months, for a total of approximately 24 months of active enrollment.

Outcome Measures

Primary Outcome Measures:

Safety: Risks associated with DBS for alcoholism

Efficacy: Alcohol consumption as measured by Alcohol Timeline Followback (TLFB).

Secondary Outcome Measures:

Secondary outcome measures include: 1) change in processing of rewards and punishments as measured in decision-making tasks, 3) change in mood as measured by Comprehensive

Psychopathological Rating Scale (CPRS), 4) change in participation in social, physical, and

rehabilitative activities as measured by the Mayo-Portland Adaptability Inventory-4 (MPAI-4), 5) change in overall life satisfaction as measured by the Satisfaction with Life Scale (SWLS), 6) change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS), and (7) number of alcohol relapses and time to alcohol relapse. ;

Related Conditions & MeSH terms

• Alcoholism

• NCT number: NCT01798888
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 30, 2012
• Completion date: November 13, 2015