Deep Brain Stimulation for Refractory Alcoholism

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.