Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
GHB (gamma hydroxybutyrate), also known as “liquid ecstasy”, is a widely-used drug. Although it was originally developed as an anaesthetic (sedative), it is often taken recreationally because it is thought to create feelings of relaxation, euphoria and increased libido. GBL (gamma-butyrolactone) is a GHB “prodrug” as it is converted to GBH in the body, causing similar effects. Use of these drugs is more common in groups such as clubbers and the lesbian, gay, bisexual and transgender (LGBT) communities. GHB/DBL can be very addictive if they are used regularly, and users can become dependent on it to function normally. Withdrawal symptoms can be very severe, often causing tremor, sweating, anxiety, agitation and confusion, as well as more serious psychological problems such as delirium and psychosis (losing touch with reality). The current treatment options for people detoxing from GHB/GBL are tranquilizers (benzodiazepines) which help to make people less anxious. In many cases, these drugs are not very effective at combating withdrawal symptoms on their own. One promising alternative treatment approach is to add in a second medication, Baclofen, as it has a calming effect on the brain. The aim of this study is to find out whether prescribing baclofen in addition to a benzodiazepine reduces symptoms during GHB/GBL withdrawal compared to treatment with a benzodiazepine alone.

Who can participate?
Adults who are detoxing from GBH/GBL

What does the study involve?
Participants are randomly allocated to be treated with benzodiazepine either with or without baclofen, and are assessed to find out whether this reduces symptoms during GHB/GBL withdrawal.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Addiction Directorate, St. Pancras Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2015 to July 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Yash Patel

Trial website

Contact information



Primary contact

Mr Yash Patel


Contact details

Addiction Directorate
St. Pancras Hospital
4 St. Pancras Way
United Kingdom

Additional identifiers

EudraCT number

2013-005319-28 number

Protocol/serial number


Study information

Scientific title

Improving GHB withdrawal with baclofen (The GHB Trial)


Study hypothesis

This feasibility study aims to establish optimal recruitment and assessment to investigate whether prescribing baclofen in addition to a benzodiazepine reduces symptoms during GHB/GBL withdrawal compared to treatment with a benzodiazepine alone.

Ethics approval

Dulwich Research Ethics Committee, 10/12/2014, ref: 14/LO/1608

Study design

Multi-centre randomised double-blind placebo-controlled clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Mental Health; Subtopic: Addictions; Disease: Addictions, Addictive Substances– illegal drugs


Baseline Assessment, Pre-detox assessments - 1 visit; Day 30 assessment, Via telephone call or Face to face; Detoxification visits, Day 1-10 visits; Full written informed consent, Obtained by research team - 20 mins; Follow Up Length: 1 month(s); Study Entry : Single Randomisation only

Intervention type



Not Applicable

Drug names


Primary outcome measures

1. Optimal recruitment rate and strateries is determined at the end of the recruitment period
2. Characteristics of outcome measures are determined at the end of the recruitment period

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

Planned Sample Size: 88; UK Sample Size: 88; Description: The aim is to recruit 88 research participants undergoing GHB/GBL detoxification, 60 planned outpatients and 28 unplanned inpatients.

Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Addiction Directorate, St. Pancras Hospital
4 St. Pancras Way
United Kingdom

Sponsor information


Central and Northwest London NHS Foundation Trust (UK)

Sponsor details

Greater London House
Hampstead Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in:

Publication citations

Additional files

Editorial Notes

30/06/2016: Publication reference added. 14/06/2016: Plain English summary added.