Improving GHB withdrawal with baclofen.

Improving GHB withdrawal with baclofen (The GHB Trial) - The GHB Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005319-28-GB

Enrollment

100

Registered

2015-07-15

Start date

2015-03-13

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GHB/GBL Withdrawal Syndrome

Interventions

Trade Name: Baclofen - generic product Product Name: Baclofen Pharmaceutical Form: Tablet INN or Proposed INN: Baclofen CAS Number: 1134

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Feasibility of a full scale RCT; Timepoint(s) of evaluation of this end point: Assessments shall be carried out at: - Baseline - Daily from pre-load up to last day of detoxification, maximum 12 days - Follow-up on Day 30 ; Secondary Objective: - Examine withdrawal symptoms and complications such as delirium and requirement for treatment escalation during detoxification in two populations: those presenting to a busy London emergency department requiring immediate acute withdrawal management (unplanned) and those presenting to a specialist outpatient ‘club drug’ clinic requiring planned GHB detoxification. Treatment escalation is defined as admission to ICU for those presenting to emergency department (unplanned) and admission to general hospital for those in club drug clinic (planned). - Examine as part of a planned detoxification whether starting baclofen 2 days prior to stopping GHB/GBL (preloading) confers additional benefits in our proposed outcome measures. - Monitor recruitment rate and manage any difficulties. - Examine impact of GHB/GBL withdrawal on anxiety, depression, sleep, quality of life. - Examine impact of study participation on GHB/GBL use up to 30 days post-randomisation. - Explore research pa ; Primary end point(s): The primary focus of this study is to assess the feasibility of undertaking a definitive trial. In particular we will characterize optimal recruitment rate and strategies and characteristics of the proposed primary outcome measure (symptom severity, complications, requirement for treatment escalation).	—

Measure

Time frame

Main Objective: Feasibility of a full scale RCT; Timepoint(s) of evaluation of this end point: Assessments shall be carried out at: - Baseline - Daily from pre-load up to last day of detoxification, maximum 12 days - Follow-up on Day 30 ; Secondary Objective: - Examine withdrawal symptoms and complications such as delirium and requirement for treatment escalation during detoxification in two populations: those presenting to a busy London emergency department requiring immediate acute withdrawal management (unplanned) and those presenting to a specialist outpatient ‘club drug’ clinic requiring planned GHB detoxification. Treatment escalation is defined as admission to ICU for those presenting to emergency department (unplanned) and admission to general hospital for those in club drug clinic (planned). - Examine as part of a planned detoxification whether starting baclofen 2 days prior to stopping GHB/GBL (preloading) confers additional benefits in our proposed outcome measures. - Monitor recruitment rate and manage any difficulties. - Examine impact of GHB/GBL withdrawal on anxiety, depression, sleep, quality of life. - Examine impact of study participation on GHB/GBL use up to 30 days post-randomisation. - Explore research pa ; Primary end point(s): The primary focus of this study is to assess the feasibility of undertaking a definitive trial. In particular we will characterize optimal recruitment rate and strategies and characteristics of the proposed primary outcome measure (symptom severity, complications, requirement for treatment escalation).

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: n/a; Secondary end point(s): Not applicable for this feasibility study. Data for our proposed secondary outcomes in the definitive trial will include change in anxiety, depression, sleep as well as relapse to GHB/GBL use or change in other illicit drug or alcohol use 30 days after randomisation. We will examine withdrawal symptoms and complications such as delirium and requirement for treatment escalation during detoxification in two populations: those presenting to an emergency department requiring immediate acute withdrawal management (unplanned) and those presenting to a specialist outpatient ‘club drug’ clinic requiring GHB/GBL detoxification (planned). We will also identify appropriate criteria e.g. benzodiazepine requirement or withdrawal score for minimisation or stratification in the full RCT.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: n/a; Secondary end point(s): Not applicable for this feasibility study. Data for our proposed secondary outcomes in the definitive trial will include change in anxiety, depression, sleep as well as relapse to GHB/GBL use or change in other illicit drug or alcohol use 30 days after randomisation. We will examine withdrawal symptoms and complications such as delirium and requirement for treatment escalation during detoxification in two populations: those presenting to an emergency department requiring immediate acute withdrawal management (unplanned) and those presenting to a specialist outpatient ‘club drug’ clinic requiring GHB/GBL detoxification (planned). We will also identify appropriate criteria e.g. benzodiazepine requirement or withdrawal score for minimisation or stratification in the full RCT.

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Countries

United Kingdom

Contacts

Public ContactAngela Williams

Central and North West London NHS Foundation Trust

baclofen.noclor@nhs.net020 3317 3765

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026