Optimizing Pharmacotherapy for Bipolar Alcoholics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
研究概览
简要总结
The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder
排除标准
- •Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
- •Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
- •Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
- •Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
- •Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery
- •Pregnancy
- •Inability or unwillingness to use contraceptive methods
- •Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol
研究组 & 干预措施
Naltrexone add on to valproate
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate
干预措施: Naltrexone hydrochloride (Drug)
Placebo add on to valproate
Placebo comparator one capsule daily for 12 weeks add on to valproate
干预措施: Placebo (Other)
结局指标
主要结局
Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
时间窗: 12 weeks
次要结局
- % Subjects Abstinent(12 weeks)
研究者
Ihsan Salloum
Professor of Psychiatry
University of Miami