NCT00901875已完成4 期
An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 8
- 主要终点
- Retention in treatment
研究概览
简要总结
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 20 years of age or older at screening visit.
- •Subjects must meet DSM-IV/COWS1,2 criteria for opiate dependence. (COWS total score ≥5)
- •Subjects must have a positive urine drug screen (dipstick test) for an opiate or morphine at study entry
- •Subject is seeking treatment with the desire to discontinue opiate use as an initial goal but willing to consider and accept longer treatment if necessary.
- •Subject is in good physical health or, if he/she has a medical condition needing ongoing treatment, must be in the care of a physician who is willing to take responsibility for such treatment and work with the study physician. Study physicians able to manage the subject for his/her general medical condition, may be assigned this role. These same conditions apply in case of subjects with psychiatric disorder(s) needing ongoing treatment.
- •Subject is agreeable to and capable of signing informed consent form.
- •Females of childbearing potential must have a negative pregnancy test and agree to use a double barrier method or condoms/diaphragm and spermicide contraceptive method during the study.
排除标准
- •Women who are pregnant, lactating or breast feeding.
- •Subjects have any acute medical condition that would make participation, in the opinion of the treating physician or the principal investigator, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease).
- •Subjects have clinically significant liver disease.
- •Subjects who have demonstrated a previous hypersensitivity to buprenorphine or naloxone.
- •Subjects who are considered an immediate risk for suicide, are acutely psychotic, severely depressed, or in need of inpatient treatment.
- •Subjects who are dependent on alcohol, benzodiazepines or other drugs of abuse (except tobacco) to the point of requiring immediate medical attention.
- •Subjects received methadone treatment within the last 30 days since screening visit.
- •Subjects have any pending legal action that could prohibit continued participation.
- •Subjects have participated in other clinical studies within the past 30 days.
- •Subjects who are expecting to leave the clinic geographic area prior to study completion.
研究组 & 干预措施
Suboxone, maximum 8mg
Experimental
干预措施: Buprenorphine + naloxone (Suboxone) (Drug)
Buprenorphine + naloxone
Experimental
干预措施: Buprenorphine + naloxone (Suboxone) (Drug)
Buprenorphine + naloxone (Suboxone)
Experimental
干预措施: Buprenorphine + naloxone (Suboxone) (Drug)
结局指标
主要结局
Retention in treatment
时间窗: weekly up to 13 weeks
次要结局
未报告次要终点
研究者
研究点 (8)
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