NCT00000446已完成2 期
Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)2 个研究点 分布在 1 个国家开始时间: 1999年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial.
All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder.
- •Laboratory tests for blood and urinalysis must be within normal limits.
- •Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions.
- •Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal.
排除标准
- •Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days.
- •Currently suicidal.
- •Medical reasons not to receive drug therapy.
- •Allergy or hypersensitivity to selective serotonin inhibitor antidepressants.
- •Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.
- •Liver function test greater than 2 times the normal level
- •Require ongoing therapy with another psychoactive drug during the study period.
- •Females who are pregnant or lactating.
研究者
研究点 (2)
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