The largest ever trial to investigate if ketamine-assisted therapy could help people with alcohol problems to stop drinking is recruiting participants, the University of Exeter has announced.
The trial will initially be delivered at eight NHS sites across the country, with the first patients now being screened for eligibility. The £2.4m Multicentre investigation of ketamine for reduction of alcohol relapse (MORE-KARE) is being led by the University of Exeter and co-funded by the National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC) and Awakn Life Sciences.
Early research in the 1980s found ‘promising’ reductions in alcohol relapse rates following ketamine treatment, with more recent studies also showing that the drug has a ‘fast-acting anti-depressant’ effect, the university says. The latest phase III trial builds on the positive initial findings from an earlier phase II investigation, which showed that ketamine was ‘safe and tolerable’ for people with severe alcohol use disorder.
Participants who had a combination of ketamine and therapy in the earlier trial were found to go from daily drinking to remaining sober for almost 90 per cent of the time over a six-month period. However, the researchers made it clear that they were ‘certainly not’ advocating taking ketamine outside of a clinical context.
‘Street drugs come with obvious risks, and it’s the combination of a low dose of ketamine and the right psychological therapy that is key, as is the expertise and support of clinical staff,’ said Professor Celia Morgan at the time. A recent pilot study by the KARE team found that ketamine may make people more receptive to mindfulness therapy, increasing engagement and improving treatment outcomes.
Participants in the current trial will be randomly allocated to receive a different dose of ketamine infusion via drip along with psychological support sessions with a therapist. Both the ketamine dose and type of psychological support will be randomly assigned by computer, with neither the participant nor the research team knowing who has been assigned what. The participants’ alcohol use will be monitored via drink diaries and self-breathalysing, which will be followed up in person at three and six-month intervals.
‘Alcohol problems affect not only the individual but families, friends and communities, and related deaths have increased still further since the pandemic,’ said consultant psychiatrist Professor Rupert McShane. ‘Alcohol-related harm is estimated to cost the NHS around £3.5 bn each year, and wider UK society around £40 bn. We urgently need new treatments. If this trial establishes that combined ketamine and therapy works, this will be a step closer towards seeing it used in the NHS, to help people turn their lives around.’
Full details here