Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.
研究概览
简要总结
The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to understand if people receiving valproate will have a better recovery than people receiving the standard treatment for alcohol dependence: naltrexone.
详细描述
Veterans are vulnerable to develop complex forms of addictive disorders characterized by the presence of traumatic brain injury and psychiatric conditions such as post-traumatic stress disorder and mood disturbances. Alcohol use disorders are frequently observed among veterans and exert a detrimental effect on community reintegration after deployment. Attending to this veteran health problem, the VA is devoting extraordinary efforts to develop adequate treatment strategies. In this study we will evaluate treatment outcomes and identify specific factors that influence alcohol use disorders treatment response in a VA Intensive Outpatient Program offering rehabilitation treatment to the growing number of veterans with alcohol use disorders. Cooperation between researchers and clinical staff will allow optimizing treatment strategies that enhance the recovery of veterans with alcohol use disorders.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Veterans attending alcohol use disorders rehabilitation treatment within the VA
- •Presence of a diagnosis of alcohol dependence according to DSM-IV
- •A history of heavy drinking
- •Absence of withdrawal symptoms
排除标准
- •Evidence of other substance abuse different from nicotine or cannabis (DSM-IV criteria) or by 2 consecutive positive urine drug screens
- •Unstable medical conditions such as severe heart disease, liver or renal failure or evidence of neoplasia.
- •Liver Enzymes (ALT, AST) serum levels >3 times the upper limit of normal
- •Unstable psychiatric conditions that requires treatment in a more structured setting (i.e. active SI, worsening psychotic symptoms or acute mania)
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Requiring therapy with valproate or naltrexone or has a history of significant side effects from either study drug
- •Requiring therapy with topiramate, lamotrigine or carbamazepine
- •Requiring chronic treatment with opioid analgesics for refractory pain
- •Failed 3 previous intensive alcohol rehabilitation programs in the past 2 years
研究组 & 干预措施
Arm 1
sodium valproate
干预措施: Valproate (Drug)
Arm 2
naltrexone
干预措施: Naltrexone (Drug)
结局指标
主要结局
Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.
时间窗: 24 weeks
次要结局
未报告次要终点