CTRI/2024/06/069491招募中3 期
To study the efficacy and safety of Baclofen versus Baclofen and Naltrexone as Anticraving agents in patients of Alcohol Dependence with Alcoholic Liver Disease - NI
Rahul0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Aged 18 to 60 years
- •2. Alcohol Dependence according to the DSM-5-TR
- •3.JELLINEK’s alcoholic type gamma, delta and epsilon e type
- •4.Adequate cognition and language skills to give valid consent and to complete research interviews
- •5.Written informed consent
- •6. Written informed consent for naltrexone, if applicable
排除标准
- •1.Active major psychiatric disorder except alcohol dependence
- •2.Pregnancy or lactating women
- •3.Dependence on other substances except alcohol and nicotine
- •4. Opioid abuse, opioid dependence or opioid agonist treatment, or likely need for opioid treatment
- •5. Any evidence of alcoholic cirrhosis or advanced fibrosis, either clinically or through relevant investigations including fibroscan
- •6.Lack of stable housing or contact phone number
- •7.Previous hypersensitivity to baclofen or naltrexone
- •8.Any pharmacotherapy related to alcohol dependence or ALD before enrolment
- •9.Contra-indications for baclofen treatment were uncontrolled epilepsy, patent hepatic encephalopathy, and renal failure
- •10. Contra-indication for naltrexone – Acute/ Fulminant liver failure
研究者
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