The National Institute for Health and Care Research (NIHR) and Medical Research Council (MRC) are funding a new clinical trial to investigate whether ketamine-assisted therapy can help people with severe alcohol-use disorder stop drinking.
Patients are now being recruited to the trial which will be led by the University of Exeter and delivered across eight NHS sites initially. Additional investment for the research is coming from the biotech company Awakn Life Sciences.
Promising results
The phase III trial will build on positive earlier results from a phase II study which suggested that ketamine combined with therapy treatment was safe and tolerable for those with severe alcohol-use disorder, with participants going from drinking daily to remaining sober 86% of the time (over a six-month period).
“More than half a million UK adults have serious alcohol problems that require help, yet only one in five of those get treatment,” explained trial lead and University of Exeter professor, Celia Morgan.
She added: “Current treatments have low success rates - we know that three out of four people who quit alcohol will be back drinking heavily after a year. This new trial is helping to fill the gap in the urgent search for new treatments.
“We’re excited that the NIHR have funded this study, which is the largest study of ketamine combined with psychological therapy to take place anywhere in the world.”
Alcohol-related harm is estimated to cost the NHS in England £3.5bn a year.
The study
The Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse (MORE-KARE) will randomly allocate patients to two arms of the trial – each side will receive a different dose of ketamine infusion as well as psychological support via a therapist. The dosage and type of support will be randomly assigned via a computer.
Participants will self-monitor via drink diaries and breathalysing themselves, while also being followed up with in person at three months and six months.
Exeter and Oxford are the sites currently recruiting, with more expected soon. The study is being funded through Efficacy and Mechanism Evaluation Programme.
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