IRCT201506261556N78已完成3 期
Comparison of Opium Tincture (OT) and Methadone for Maintenance Treatment of Opioid Dependence: A Randomized Double-blind Controlled Clinical Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- no limit 至 no limit（—）
- 性别
- All
入选标准
- •Opioid dependence as confirmed by DSM V diagnostic criteria; Willingness and ability to adhere to study protocol and follow-up schedule as determined through the pre-randomization period; Provide written informed consent; Females of childbearing capacity must agree to use an acceptable method of birth
- •control approved by the study investigator throughout the study.
- •Exclusion criteria:
- •Active participant in another treatment program for opioid dependence within 14 days before inclusion in the study; Severe hepatic impairment (decompensated liver disease): a contraindication for methadone and its potential to precipitate hepatic encephalopathy; Hypersensitivity to methadone syrup or other ingredients in the formulation; Pregnancy; Severe chronic respiratory disease; Head injury and raised intracranial pressure: Respiratory depressant effects (with CO2 retention and secondary elevation of CSF pressure) may be markedly exaggerated in the presence of head injury, or a pre-existing increase in intracranial pressure. May produce effects that obscure the clinical course in participants with head injuries; Biliary tract disease: may cause constriction of sphincter of Oddi; Monoamine oxidase inhibitors use within 14 days of the study.
排除标准
- 未提供
研究者
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