Optimizing Pharmacotherapy for Bipolar Alcoholics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Pharmacotherapy for Bipolar Alcoholics

Conditions
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Bipolar Disorder, Alcohol Dependence

Intervention / Treatment
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* Drug: Naltrexone hydrochloride
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone add on to valproate<br>Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate | Drug: Naltrexone hydrochloride<br>* Naltrexone hydrochloride 50 mg capsule daily for 12 weeks<br>* Other names: Revia;|
| Placebo Comparator: Placebo add on to valproate<br>Placebo comparator one capsule daily for 12 weeks add on to valproate | Other: Placebo<br>* Placebo arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Subjects Abstinent | Proportion of subjects abstinent during the last 4 weeks of the trial | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone