Optimizing Pharmacotherapy for Bipolar Alcoholics

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Miami
• Treatments: Naltrexone; Valproic Acid

Criteria

Inclusion Criteria:

• Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder

Exclusion Criteria:

• 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