The GHB Trial
Research type
Research Study
Full title
Improving GHB withdrawal with baclofen (The GHB Trial)
IRAS ID
142525
Contact name
Anne Lingford-Hughes
Contact email
Sponsor organisation
RMG Manager, West London Mental Health Trust R&D Office
Eudract number
2013-005319-28
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
GHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) and 1, 4-butanediol are central nervous system depressants whose street names include ‘G’ and ‘liquid ecstasy’. They are used recreationally for their sedative, stimulant and pro-sexual effects. Although overall population prevalence is low, use of these drugs is more common in groups such as clubbers and the lesbian, gay, bisexual and transgender (LGBT) communities. GHB/GBL is associated with severe dependence and GHB/GBL withdrawal has some similar features to alcohol withdrawal, including tremor, sweating, anxiety, agitation and confusion; however it is generally more severe, has a more rapid onset and more prominent neuropsychiatric features such as delirium and psychosis. Currently, benzodiazepines are prescribed for the treatment of GHB/GBL withdrawal to help manage withdrawal. However, benzodiazepines alone often provide inadequate management of withdrawal in all patients. One promising alternative treatment approach is to add in a second medication, Baclofen, due to its effect on calming the brain. 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.
This feasibility study is a randomised, double-blind, placebo-controlled clinical trial which will recruit participants above 18 who are: i) either in active withdrawal ii) have underlying GHB/GBL dependence and wish to undergo GHB/GBL detoxification or iii) are thought to have underlying dependence and are at risk of acute withdrawal.
We aim to recruit 100 participants undergoing GHB/GBL detoxification, 60 planned outpatients and 40 unplanned inpatients. The planned outpatient recruitment will take place at Central and North West London (CNWL) Club Drug Clinic, London and unplanned inpatient recruitment will take place in St. Thomas’ Hospital, London. The study is sponsored by CNWL NHS Foundation Trust and funded by NIHR Research for Patient Benefit.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1608
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion