Clinical trial NCT00302133: Optimizing Pharmacotherapy for Bipolar Alcoholics
Official title: Optimizing Pharmacotherapy for Bipolar Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bipolar Disorder
Alcohol Dependence
Keywords: Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2006-03-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.

Eligibility 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

Primary outcomes:
measure: Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
timeFrame: 12 weeks
Secondary outcomes:
measure: % Subjects Abstinent
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Ihsan M Salloum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: