Status:
COMPLETED
Optimizing Pharmacotherapy for Bipolar Alcoholics
Lead Sponsor:
University of Miami
Conditions:
Bipolar Disorder
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.
Detailed Description
Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened r...
Eligibility Criteria
Inclusion
- Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder
Exclusion
- 1\) Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
- 2\) Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
- 3)Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
- 4\) Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
- 5)Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery
- 6)Pregnancy
- 7)Inability or unwillingness to use contraceptive methods
- 8)Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00302133
Start Date
May 1 2006
End Date
July 1 2013
Last Update
May 17 2016
Active Locations (1)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136