Improving GHB withdrawal with baclofe

Not Applicable

Completed

• Conditions: Topic: Mental Health; Subtopic: Addictions; Disease: Addictions, Addictive Substances– illegal drugs; Mental and Behavioural Disorders; GHB/GBL withdrawal syndrome

• Registration Number: ISRCTN59911189
• Lead Sponsor: Central and Northwest London NHS Foundation Trust (UK)

Brief Summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27677382

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Study Completion: 2016-07-31
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Optimal recruitment rate and strateries is determined at the end of the recruitment period<br> 2. Characteristics of outcome measures are determined at the end of the recruitment period<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration