Improving GHB withdrawal with baclofen.

Phase 1

• Conditions: GHB/GBL Withdrawal Syndrome; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-005319-28-GB
• Lead Sponsor: Central and North West London NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-15
• Study Completion: 2017-04-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified