Optimizing Pharmacotherapy for Bipolar Alcoholics

University of Miami

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bipolar Disorder; Alcohol Dependence

Treatments: Drug: Naltrexone hydrochloride; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00302133

RO1-AA015385-01 -Salloum

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Naltrexone add on to valproate

Experimental group

Description:

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

Treatment:

Drug: Naltrexone hydrochloride

Placebo add on to valproate

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo