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
Additional identifiers
EudraCT number
2013-005319-28
ClinicalTrials.gov number
Protocol/serial number
18715
Study information
Scientific title
Improving GHB withdrawal with baclofen (The GHB Trial)
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health; Subtopic: Addictions; Disease: Addictions, Addictive Substances– illegal drugs
Intervention
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
Drug
Phase
Not Applicable
Drug names
Baclofen
Primary outcome measure
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
30/09/2015
Overall trial end date
31/07/2016
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
30/09/2015
Recruitment end date
31/07/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addiction Directorate, St. Pancras Hospital
4 St. Pancras Way
London
NW1 0PE
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
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
Basic results (scientific)
Publication list
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27677382