Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clean urine THC samples
研究概览
简要总结
Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. We predict that combined pharmacological treatment and cognitive-behavior therapy will help patients to abstain from using using marijuana and it will alleviate their marijuana withdrawal symptoms.
详细描述
Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome characterized by symptoms of anxiety, irritability, negative mood, physical symptoms and decreased appetite. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. 40 patients will be blindly randomized to either active or placebo escitalopram 10mg/day, for 12 weeks followed bt 12 weeks of follow-up.
Inclusion criteria include:
- Men and women age 20-45
- DSM-IV diagnosis of THC dependence.
Exclusion criteria include:
- Dependence on other drugs or alcohol
- Bipolar Disorder or Schizophrenia, Major depression, suicidal ideation psychotic symptoms or violent thoughts
- Current treatment with anti-depressant medication
- Neurological disease
- Physical illness (hypothyroidism, severe anemia, renal failure)
- Past severe effects of SSRIs.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 20-45
- •DSM IV criteria of marijuana dependence.
排除标准
- •Other drug or alcohol dependence
- •Bipolar disorder, schizophrenia, major depression, suicidal ideation, psychotic symptoms or violent thoughts
- •Physical illness including hypothyroidism, neurological disease, severe anemia, and renal failure
- •Past severe side effects of SSRIs.
研究组 & 干预措施
A
Escitalopram + cognitive-behavior treatment
干预措施: Escitalopram (Drug)
B
Placebo + cognitive-behavior therapy
干预措施: Escitalopram (Drug)
结局指标
主要结局
Clean urine THC samples
时间窗: Every 2 weeks
次要结局
- Questionnaire ratings of anxiety and depression and withdrawal symptoms(Every week of treatment)