This Phase III, multi-site trial (n=280) will examine the effectiveness of ketamine-assisted psychological therapy for reducing alcohol relapse in individuals with severe alcohol use disorder (AUD).
Participants will be randomly assigned to receive either therapeutic or subtherapeutic doses of ketamine, combined with either psychological therapy or an alcohol education package. The treatment regimen includes three intravenous ketamine infusions at weekly intervals, alongside either seven sessions of psychological therapy or alcohol education over six months.
This study builds on a previous phase II trial which demonstrated that ketamine combined with psychological therapy could significantly reduce alcohol consumption compared to placebo. Conducted across up to 10 NHS sites in the UK, this trial aims to establish whether this combined treatment approach can be effective enough to be implemented in NHS settings. Participants will undergo medical assessments, including blood and urine tests, and psychological evaluations to track alcohol usage and mental health throughout the trial.
The study is set to run from 25 June 2024 to 31 December 2025. Eligible participants are adults with severe AUD who are abstinent from alcohol at randomisation and willing to comply with trial procedures. Key exclusion criteria include current use of other relapse prevention medications, uncontrolled hypertension, and a history of ketamine use disorder.
Trial Details
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. 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.NCT Number 12934
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