Optimizing Pharmacotherapy for Bipolar Alcoholics

Phase 1

Completed

• Conditions: Alcohol Dependence; Bipolar Disorder
• Interventions: Drug: Naltrexone hydrochloride; Other: Placebo

• Registration Number: NCT00302133
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-13
• Study Start: 2006-05
• Primary Completion: 2013-04
• Study Completion: 2013-07
• Results First Submitted: 2014-10-20
• Results First Submitted QC: 2014-11-04
• Results First Posted: 2014-11-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone add on to valproate	Naltrexone hydrochloride	Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate
Placebo add on to valproate	Placebo	Placebo comparator one capsule daily for 12 weeks add on to valproate

Primary Outcome Measures

Name	Time	Method
Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial	12 weeks

Secondary Outcome Measures

Name	Time	Method
% Subjects Abstinent	12 weeks	Proportion of subjects abstinent during the last 4 weeks of the trial

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States