Optimizing Pharmacotherapy for Bipolar Alcoholics

NCT ID: NCT00302133

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Bipolar Disorder; Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naltrexone add on to valproate

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

Group Type: EXPERIMENTAL

Naltrexone hydrochloride

Intervention Type: DRUG

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

Placebo add on to valproate

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo arm

Interventions

Naltrexone hydrochloride

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

Intervention Type: DRUG

Placebo

Placebo arm

Intervention Type: OTHER

Other Intervention Names

Revia

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ihsan Salloum

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ihsan M Salloum, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

Other Identifiers

R01AA015385-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RO1-AA015385-01 -Salloum

Identifier Type: -

Identifier Source: org_study_id