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Optimizing Pharmacotherapy for Bipolar Alcoholics

Primary Purpose

Bipolar Disorder, Alcohol Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Naltrexone hydrochloride
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naltrexone add on to valproate

Placebo add on to valproate

Arm Description

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate

Placebo comparator one capsule daily for 12 weeks add on to valproate

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

% Subjects Abstinent
Proportion of subjects abstinent during the last 4 weeks of the trial

Full Information

First Posted
March 9, 2006
Last Updated
April 16, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00302133
Brief Title
Optimizing Pharmacotherapy for Bipolar Alcoholics
Official Title
Optimizing Pharmacotherapy for Bipolar Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Alcohol Dependence
Keywords
Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone add on to valproate
Arm Type
Experimental
Arm Description
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate
Arm Title
Placebo add on to valproate
Arm Type
Placebo Comparator
Arm Description
Placebo comparator one capsule daily for 12 weeks add on to valproate
Intervention Type
Drug
Intervention Name(s)
Naltrexone hydrochloride
Other Intervention Name(s)
Revia
Intervention Description
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo arm
Primary Outcome Measure Information:
Title
Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
% Subjects Abstinent
Description
Proportion of subjects abstinent during the last 4 weeks of the trial
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihsan M Salloum, MD, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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Optimizing Pharmacotherapy for Bipolar Alcoholics

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