What is the GHB trial?
The trial is investigating how to help people who are dependent on GHB/GBL. In particular, the trial is assessing which medications are most useful when people trying to stop using GHB/GBL, sometimes called detoxification or ‘detox’. The aim of this study is to establish whether prescribing baclofen in addition to a benzodiazepine reduces symptoms during GHB/GBL withdrawal compared to treatment with a benzodiazepine alone.
You may be able to take part if you are over 18 years of age, take GHB/GBL daily and want to stop, you are linked with a local drug treatment service and happy to consent to take part in this study.
What will happen to me if I take part?
When you choose to undertake a GHB/GBL ‘detox’, your doctor prescribes you a benzodiazepine which helps in reducing symptoms during withdrawal. There are early reports which suggest that baclofen, which acts on the same receptors in the brain as GHB/GBL, helps in reducing symptoms during withdrawal.
Baclofen has been used for many years to relieve muscle spasms, cramping or tightness caused by diseases such as cerebral palsy and multiple sclerosis and it is a licensed medicine in the UK for these indications.
If you participate in this study, we will ask you to meet with one of the team who will explain the trial in more detail and give you the opportunity to ask any questions you have. You will be provided with a full information sheet and if you agree to participate, will be asked to sign a consent form. Then you will be randomly assigned to one of three groups, as shown below. The study medication that you receive will be based on this allocation and you will have the same chance of being put into each of these groups (one in three for people coming into the study):
Preload (2 days) during detoxification (up to 10 days)
Group 1 Baclofen baclofen (+ benzodiazepine)
Group 2 Placebo baclofen (+ benzodiazepine)
Group 3 Placebo placebo (+ benzodiazepine)
You will be asked to complete some short questionnaires which will help us assess withdrawal effects and we will also monitor your vital signs like blood pressure and pulse. We will ask for your past medical history and your use of alcohol and drugs including GHB/GBL. These study related procedures will only require up to 5-10 minutes of your additional time during your detox visit.
You’ll only require visiting for up to 11 days for this study (1 visit for and up to 10 day’s visits for detox). We will contact you on a weekly basis to check how you’re feeling after your detoxification treatment. Around one month after the start of your detoxification, we will call you to check how are getting on, ask about your alcohol and drug use and about any medical or support service that you’ve used during the time since finishing the detoxification. Your participation in the study will end after this and you’ll be referred to your local drug treatment service.
What if I am already being treated somewhere else?
Even if you are being treated at another drug treatment service, you can still participate in the trial. The trial team will work with your local drug treatment service team to ensure that your care is co-ordinated across both services. Once your detoxification is completed, the trial team will make sure that your local drug treatment service team is ready to support you.
Where can I get further information?
Thank you for showing interest in this trial. If you would like to get further information on this project, please email us on email@example.com
The GHB trial is funded by NIHR RfPB (Research for Patient Benefit) and sponsored by Central and North West London NHS Foundation Trust. The chief investigator of this study is Prof Anne Lingford-Hughes and this study is approved by London – Dulwich Research Ethics Committee (REC Ref: 14/LO/1608)