Optimizing Pharmacotherapy for Bipolar Alcoholics
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Bipolar Disorder, Alcohol Dependence
In brief
The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.
Key facts
- Study ID
- NCT00302133
- Run by
- University of Miami
- People needed
- 88
- Starts
- 2006-05-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2016-05-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder
You may not qualify if…
- 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
Where it is running
- University of Miami Miller School of Medicine — Miami, Florida, United States
Full record on ClinicalTrials.gov
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