Conditions: Bipolar Disorder Alcohol Dependence
Keywords: Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: yes

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.

Arms:
arm 1: Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate arm 2: Placebo comparator one capsule daily for 12 weeks add on to valproate

Interventions: intervention 1: Naltrexone hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Naltrexone hydrochloride 50 mg capsule daily for 12 weeks intervention 2: Placebo arm

Protocol document: