Optimizing Pharmacotherapy for Bipolar Alcoholics

University of Miami88 enrolled

Overview

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bipolar Disorder Alcohol Dependence

Interventions

Naltrexone hydrochlorideDRUG

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

PlaceboOTHER

Placebo arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Miller School of Medicine

Miami, Florida, United States

Outcomes

Primary Outcomes

Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial

Time frame: 12 weeks

Secondary Outcomes

% Subjects Abstinent

Proportion of subjects abstinent during the last 4 weeks of the trial

Time frame: 12 weeks

Data from ClinicalTrials.gov

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