Valproate Efficacy in Cocaine-Bipolar Comorbidity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Change From Baseline in Percentage of Cocaine-abstinent Days
研究概览
简要总结
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.
详细描述
Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide.
The aims of this study are:
- Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder.
- Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome.
- Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.
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
- •Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder
排除标准
- •Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
- •Current DSM-IV criteria for dependence on substances other than cocaine, 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, or liver disease.
- •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
Lithium carbonate add on Placebo
Lithium carbonate started and stabilized then participants randomized to placebo
干预措施: Placebo (Drug)
Lithium carbonate add on Placebo
Lithium carbonate started and stabilized then participants randomized to placebo
干预措施: Lithium Carbonate (Drug)
Lithium carbonate add on Valproate
Lithium carbonate started and stabilized then participants randomized to Valproate
干预措施: Valproate (Drug)
Lithium carbonate add on Valproate
Lithium carbonate started and stabilized then participants randomized to Valproate
干预措施: Lithium Carbonate (Drug)
结局指标
主要结局
Change From Baseline in Percentage of Cocaine-abstinent Days
时间窗: Week 12
Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
次要结局
- Change From Baseline in Percentage of Money Spent on Cocaine(week 12)
研究者
Ihsan Salloum
Professor of Psychiatry
University of Miami