NCT00567814已完成不适用
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
研究概览
简要总结
Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 - 50 years of age
- •Requests treatment for cocaine addiction
- •Meets the DSM-IV criteria for cocaine dependency
- •Able to provide written informed consent and comply with the study
- •Females of childbearing potential must have a negative pregnancy test and must be using adequate birth control during the study
- •Test positive for cocaine on a urinary drug screen
- •Healthy and medically stable in the opinion of the Principal Investigator
排除标准
- •Liver enzymes greater than two times normal
- •Any history of hepatitis
- •History of disorders requiring chronic treatment with steroids
- •Significantly abnormal ECG
- •Any prominent DSM-IV axis I disorders other than cocaine dependence
- •Any subject who presents as a danger to self or others in the opinion of the Principal Investigator
- •Concomitant use of methamphetamine as determined by self-reporting and verified by measurement of methamphetamine in urinary drug screen
- •Alcohol consumption greater than 4 drinks per day (1 Drink = 12 oz beer; 5 oz wine; 1.5 oz shot of liquor)
- •Any clinically significant laboratory test abnormalities
- •Use of any concomitant medication during the study that would interfere with study medications
- •Serum cortisol less than 3 µg/dl at any time before or during study
- •Treatment with an investigational product within 30 days prior to study enrollment
- •Currently seeking other forms of professional addiction treatment
- •Known allergic reaction to oxazepam or metyrapone
- •Lactose intolerance
研究组 & 干预措施
1
Active Comparator
Lower dose combination of metyrapone with oxazepam
干预措施: Metyrapone (Drug)
1
Active Comparator
Lower dose combination of metyrapone with oxazepam
干预措施: Oxazepam (Drug)
2
Active Comparator
Higher dose combination of metyrapone with oxazepam
干预措施: Metyrapone (Drug)
2
Active Comparator
Higher dose combination of metyrapone with oxazepam
干预措施: Oxazepam (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
时间窗: 6 weeks
次要结局
- Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology(6 weeks)
- Improvement in anxiety and depression symptoms(6 weeks)
研究者
研究点 (1)
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