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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Stephen
Kaar
+44 161 3581599
stephen.kaar@gmmh.nhs.uk
Prof
Celia
Morgan
+44 1392 724649
celia.morgan@exeter.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Severe alcohol use disorder
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current participant inclusion criteria as of 28/06/2024:1. Currently taking any other alcohol relapse prevention medication2. Current uncontrolled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)3. Being actively treated for a current co-morbid substance use disorder (SUD) or having been treated in the past 12 months. If the participant is currently in treatment for a comorbid SUD but is abstinent from any substance use and has a negative urine drug screen (except cannabis and benzodiazepine) participant could be included at the discretion of the investigator.4. History of ketamine use disorder as assessed by the SCID.5. Pregnant or breast-feeding6. Not willing to use effective contraception or (people of child-bearing potential) take pregnancy test.7. Use of another experimental IMP that is likely to interfere with the trial medication within 3 months of trial enrolment.8. Known allergies to ketamine or excipients of IMP.9. Meets current criteria for or has a history of any psychotic illness including substance induced psychosis.10. Current suicide risk as judged clinically and using CSSR or a history of a suicide attempt within the past year.11. BMI < 16 or > 35 kg/m²12. Positive urine drug screen for ketamine.13. Where there are “Special warnings and precautions for use for ketamine infusion” according to the SmPC.14. Where risk vs benefit ratio is not in favour of giving ketamine, with assessment made by physical examination by medically qualified trial personnel, self-report, or inspection of the medical notes.15. Received any previous ketamine treatment.
Previous participant exclusion criteria:1. Currently taking any other alcohol relapse prevention medication2. Current uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg) 3. Being actively treated for a current co-morbid substance use disorder (SUD) or having been treated in the past 12 months. If the participant is currently in treatment for a comorbid SUD but is abstinent from any substance use and has a negative urine drug screen (except cannabis and benzodiazepine) participant could be included at the discretion of the investigator. 4. History of ketamine use disorder as assessed by the SCID.5. Pregnant or breast-feeding6. Not willing to use effective contraception or (people of child-bearing potential) take pregnancy test.7. Use of another experimental IMP that is likely to interfere with the trial medication within 3 months of trial enrolment.8. Known allergies to ketamine or excipients of IMP. 9. Meets current criteria for or has a history of any psychotic illness including substance induced psychosis.10. Current suicide risk as judged clinically and using CSSR or a history of a suicide attempt within the past year.11. BMI < 16 or > 35 kg/m²12. Positive urine drug screen for ketamine. 13. Where there are “Special warnings and precautions for use for ketamine infusion” according to the SmPC. 14. Where risk vs benefit ratio is not in favour of giving ketamine, with assessment made by physical examination by medically qualified trial personnel, self-report, or inspection of the medical notes.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Stephen
Kaar
+44 161 3581599
stephen.kaar@gmmh.nhs.uk
Prof
Celia
Morgan
+44 1392 724649
celia.morgan@exeter.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Exeter and funded by National Institute for Health and Care Research; AWAKN Life Sciences.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 58776
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
