Improving GHB withdrawal with baclofen (The GHB Trial)

Central and Northwest London NHS Foundation Trust (UK)0 个研究点目标入组 7 人开始时间: 2015年10月14日最近更新: 2020年6月8日

适应症

试验速览

•1. Aged 18 years or over who is either:
•1.1. In active withdrawal
•1.2. Has underlying GHB/GBL dependence and wishes to undergo GHB/GBL detoxification
•1.3. Is thought to have underlying dependence and is at risk of acute withdrawal
•1.4. Is under the care of a drug treatment service

•1. Clinician does not deem that medication is required for management of GHB/GBL withdrawal.
•2. Lacks capacity to consent
•3. Unable to take oral medication
•4. Unable to take baclofen (according to SPC) due to:
•4.1. Known hypersensitivity to baclofen or any of the excipients
•4.2. hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
•4.3. active peptic ulceration
•4.4. porphyria.
•5. Unable to follow the study protocol due to serious mental health disorder e.g. enduring psychotic illness, suicidal intent
•6. Could be pregnant and refuses a pregnancy test.
•7. Taken any investigational drug within 30 days prior to drug administration
•8. 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
•9. Has epilepsy not well controlled either with or without medication
•10. End stage renal failure (CKD stage 5, GFR <15 mL/min)

发起方

Central and Northwest London NHS Foundation Trust (UK)