Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial
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Published version
Accepted version
Author(s)
Type
Journal Article
Abstract
Background
GHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) 1,4-butanediol
(1.4-BD) are central nervous system depressants whose street names include ‘G’ and ‘liquid
ecstasy’. They are used recreationally predominately for their stimulant and pro-sexual effects
or for sedation to help with sleep and/or to “come down” after stimulant recreational drugs.
Although overall population prevalence is low (0.1%), in some groups such as men who have
sex with men, GHB/GBL use may reach 20%. GHB/GBL dependence may be associated with
severe withdrawal with individuals presenting either acutely to Emergency Departments or to
addiction services for support. Benzodiazepines are currently prescribed for GHB/GBL
detoxification but do not prevent all complications such as behavioural disinhibition that may
require hospitalisation or admission to a High Dependency/Intensive Care Unit. The GABAB
receptor mediates most effects of GHB/GBL and the GABAB agonist, baclofen, has shown
promise as an adjunct to benzodiazepines in reducing withdrawal severity when prescribed
both during withdrawal and as a 2 day ‘pre-load’ prior to detoxification.
Methods / Design
This is a randomised, double-blind, placebo-controlled feasibility study which will recruit
participants (>18years) who are GHB/GBL dependent and wish to undergo planned GHB/GBL
detoxification or are at risk of acute withdrawal and are inpatients requiring unplanned
withdrawal. We aim to recruit 88 participants, 28 unplanned inpatients and 60 planned
outpatients.
During detoxification we will compare baclofen 10mg three times a day with placebo as an
adjunct to usual benzodiazepine regimen. In the planned outpatient arm, we will also
compare a 2-day preload of baclofen 10mg three times a day with placebo. Ratings of
GHB/GBL withdrawal, sleep, depression, anxiety as well as GHB/GBL use will be collected. The
main data analyses will be descriptive about recruitment and characterizing the impact of
adding baclofen to usual benzodiazepine regimen on measures and outcomes of GHB/GBL
withdrawal to provide estimates of variability and effect size. A qualitative approach will
evaluate research participant and clinician acceptability and data collected to inform costeffectiveness.
Discussion
This feasibility study will inform a Randomised Controlled Trial to establish whether adding
baclofen to a benzodiazepine regimen reduces the severity and complications of GHB/GBL
withdrawal.
GHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) 1,4-butanediol
(1.4-BD) are central nervous system depressants whose street names include ‘G’ and ‘liquid
ecstasy’. They are used recreationally predominately for their stimulant and pro-sexual effects
or for sedation to help with sleep and/or to “come down” after stimulant recreational drugs.
Although overall population prevalence is low (0.1%), in some groups such as men who have
sex with men, GHB/GBL use may reach 20%. GHB/GBL dependence may be associated with
severe withdrawal with individuals presenting either acutely to Emergency Departments or to
addiction services for support. Benzodiazepines are currently prescribed for GHB/GBL
detoxification but do not prevent all complications such as behavioural disinhibition that may
require hospitalisation or admission to a High Dependency/Intensive Care Unit. The GABAB
receptor mediates most effects of GHB/GBL and the GABAB agonist, baclofen, has shown
promise as an adjunct to benzodiazepines in reducing withdrawal severity when prescribed
both during withdrawal and as a 2 day ‘pre-load’ prior to detoxification.
Methods / Design
This is a randomised, double-blind, placebo-controlled feasibility study which will recruit
participants (>18years) who are GHB/GBL dependent and wish to undergo planned GHB/GBL
detoxification or are at risk of acute withdrawal and are inpatients requiring unplanned
withdrawal. We aim to recruit 88 participants, 28 unplanned inpatients and 60 planned
outpatients.
During detoxification we will compare baclofen 10mg three times a day with placebo as an
adjunct to usual benzodiazepine regimen. In the planned outpatient arm, we will also
compare a 2-day preload of baclofen 10mg three times a day with placebo. Ratings of
GHB/GBL withdrawal, sleep, depression, anxiety as well as GHB/GBL use will be collected. The
main data analyses will be descriptive about recruitment and characterizing the impact of
adding baclofen to usual benzodiazepine regimen on measures and outcomes of GHB/GBL
withdrawal to provide estimates of variability and effect size. A qualitative approach will
evaluate research participant and clinician acceptability and data collected to inform costeffectiveness.
Discussion
This feasibility study will inform a Randomised Controlled Trial to establish whether adding
baclofen to a benzodiazepine regimen reduces the severity and complications of GHB/GBL
withdrawal.
Date Issued
2016-09-27
Date Acceptance
2016-07-27
Citation
Trials, 2016, 17
ISSN
1745-6215
Publisher
BioMed Central
Journal / Book Title
Trials
Volume
17
Copyright Statement
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
License URL
Sponsor
National Institute for Health Research
Grant Number
N/A
Subjects
General & Internal Medicine
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Publication Status
Published
Article Number
472