MORE-KARE
Research type
Research Study
Full title
A multi-centre investigation of increasing alcohol abstinence with ketamine-assisted psychological therapy in severe alcohol use disorder.
IRAS ID
1008179
Contact name
Stephen Kaar
Contact email
Sponsor organisation
University of Exeter
Research summary
In the UK more than half a million adults have alcohol problems. Only 1 in 5 people with alcohol problems get treatment. Even of those who quit alcohol, 3 out of 4 will be back drinking heavily after a year. Alcohol-related harm is estimated to cost the UK NHS around £3.5 billion each year and wider UK society around £40 billion. Alcohol problems affect not only the individual but families, friends and communities. Alcohol-related deaths have increased still further since the pandemic and we urgently need new treatments. We previously ran a small phase II clinical trial in 96 people with severe alcohol problems. The treatment was 3 doses of ketamine given through a drip combined with 7 sessions of psychological therapy (KARE therapy). We found KARE therapy could reduce drinking 6 months after the start of treatment when compared to placebo. The study also found that giving psychological therapy combined with ketamine reduced drinking still further than when ketamine was given without psychological therapy. This phase III, multi-site study will build on our phase II trial and will run in up to 10 NHS sites across the UK. We will randomise 280 participants with severe alcohol use disorder (AUD) to receive 3 intravenous infusions of either a therapeutic or subtherapeutic dose of ketamine at weekly intervals. Participants will also be randomly allocated to receive either 7 sessions of psychological therapy or an alcohol eductaion package. There will be 10 appointments over 6 months. At these visits medical assessments will be carried out including blood and urine samples analysis and psychological questionnaires will look at alcohol usage and mental health in the trial. We hope to collect enough evidence to establish if this treatment works, so that it may begin to be used in NHS settings.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0800
Date of REC Opinion
2 Nov 2023
REC opinion
Further Information Favourable Opinion