Status:
WITHDRAWN
Deep Brain Stimulation for Refractory Alcoholism
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
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 possibl...
Detailed 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 t...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Enrolled in 05-AA-0121.
- Age 21-60 years at time of enrollment.
- Fulfills DSM-IV diagnostic criteria for alcohol dependence.
- Has no current DSM-IV substance dependence diagnoses except for alcoholism and nicotine dependence.
- Has demonstrated greater than 10 years of refractory symptoms of alcohol dependence.
- Has failed two or more detoxification and rehabilitation treatment programs (both inpatient and outpatient).
- Has failed two or more community and self-help programs.
- Has failed standard psychotherapeutic and pharmacological treatments.
- Is unable to remain sober for more than a 6-month period (excluding periods of incarceration, inpatient treatment programs, or in a closely supervised therapeutic community) in the last 5 years.
- Has serious psychological and/or psychosocial consequences of alcohol dependence.
- Has a stable living arrangement (e.g., living in proximity to people who will assist with monitoring subject s behavior, encouraging subjects to attend clinic visits, and providing contact information) that will provide reasonable assurance that they will participate in follow-up evaluations following DBS implantation.
- Is able to comprehend the consent form and provide informed consent.
- Is fluent in the English language.
- A physician outside of the intramural NIAAA program, who is an expert in the treatment of substance abuse, will review each candidate s coded records prior to enrollment. The purpose of this review is to assure that the candidate has severe, treatment resistant alcoholism (as defined by criteria 5-10).
- EXCLUSION CRITERIA:
- Has medical problems requiring intensive medical or diagnostic management, including:
- a diagnosis of acute myocardial infarction or cardiac arrest within the previous 6 months
- history of a neurosurgical ablation procedure
- any medical contraindications to undergoing DBS surgery
- history of hemorrhagic stroke
- life expectancy of \<3 years
- Has abnormal coagulation lab studies, defined as INR \>1.4, abnormal PT/PTT.
- Has liver function tests \> 3 times the upper limit of normal (ULN).
- Has infection with the Human Immunodeficiency Virus (HIV), because of the potential for CNS involvement which might confound the analysis of study outcomes.
- Is participating in other clinical trials that would compromise the ability to determine the safety and efficacy of this study.
- Has a past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder other than one determined to be substance induced; past or present diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment.
- Has manifested behaviors such as violence which, in the investigator s judgment, could lead to non-compliance with study procedures.
- Is unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small closed spaces (have claustrophobia), or cannot lie comfortably on their back for up to one hour
- Has known destruction and/or damage to the nucleus accumbens, ventral striatum and ventral capsule region as determined by MRI.
- Has documentation of an MRI abnormality indicative of a neurological condition that may jeopardize the subject s safety, the conduct of the study, or confound the subject s diagnosis or assessments.
- Has been evaluated and judged by a board certified psychiatrist to be either severely depressed or an imminent risk for suicide or violent behavior in spite of optimal medical treatment.
- Is unlikely or unable to complete the clinical trial because they are likely to be incarcerated while on the protocol.
- Is required to receive treatment by a court of law or is involuntarily committed to treatment.
- Is pregnant (negative pregnancy test required) or planning to become pregnant.
- Has a history of seizures (including alcohol withdrawal seizures), other than documented febrile seizures.
Exclusion
Key Trial Info
Start Date :
November 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01798888
Start Date
November 30 2012
End Date
November 13 2015
Last Update
December 17 2019
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