EUCTR2013-005319-28-GB进行中（未招募）1 期
Improving GHB withdrawal with baclofen (The GHB Trial) - The GHB Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Anyone (>18 years old) who is:
- •either in active withdrawal;
- •has underlying GHB/GBL dependence and wishes to undergo GHB/GBL detoxification
- •is thought to have underlying dependence and is at risk of acute withdrawal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •An individual will not be eligible for inclusion in this study if any of the following criteria are known to apply:
- •Clinician does not deem that medication is required for management of GHB/GBL withdrawal.
- •Lacks capacity to consent
- •Unable to take oral medication
- •Unable to take baclofen (according to SPC) due to
- •a. Known hypersensitivity to baclofen or any of the excipients
- •b. hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •c. active peptic ulceration
- •d. porphyria.
- •Unable to follow the study protocol due to serious mental health disorder e.g. enduring psychotic illness, suicidal intent
- •Could be pregnant and refuses a pregnancy test.
- •Taken any investigational drug within 30 days prior to drug administration
- •Where there are Special warnings and precautions for use” according to the SPC and where risk vs benefit ratio for prescribing is not in favour of prescribing baclofen
- •a. Has epilepsy not well controlled either with or without medication
- •b. End stage renal failure (CKD stage 5, GFR <15 mL/min)
研究者
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Improving GHB withdrawal with baclofeTopic: Mental HealthSubtopic: AddictionsDisease: Addictions, Addictive Substances– illegal drugsMental and Behavioural DisordersGHB/GBL withdrawal syndromeISRCTN59911189Central and Northwest London NHS Foundation Trust (UK)7
进行中（未招募）
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