KARE: Ketamine for reduction of Alcoholic Relapse Version 1
Research type
Research Study
Full title
A phase II, randomised, double-blind, placebo- controlled, multi-site, parallel group clinical trial to examine ketamine as a pharmacological treatment for alcohol dependence in an alcohol dependent population.
IRAS ID
173320
Contact name
Celia Morgan
Contact email
Sponsor organisation
University College London
Eudract number
2015-000222-11
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Worldwide, alcohol abuse is an escalating problem. In the UK 3.9 million adults suffer from alcohol dependence and annually around 22,000 people die from alcohol misuse. Consequences of prolonged alcohol abuse, both physically and psychologically, can be severe and costs the NHS £2.7 billion annually. Treating alcohol dependence and abstinence is key to the mental and physical recovery as well as reducing the burden on the NHS. Current treatments have high relapse rates of 70% after 6 months. Preliminary evidence indicates that 3 doses of the anaesthetic drug, ketamine, combined with psychological therapy reduces the one year relapse rates by over 40%. However, this data is only supported from controlled laboratory studies and a small uncontrolled patient study. Our primary aim is to assess if ketamine therapy is safe, well-tolerated and effective in abstinence. We also aim to examine whether ketamine alone is as effective as ketamine plus psychological therapy. This MRC grant funded multi-site study will be run at 2 NHS Hospitals. There are 4 treatment arms. We will randomise 96 detoxified alcoholics with mild depression to receive 3 weekly intravenous infusions of either ketamine or a placebo (saline). Participants will also be randomly allocated to receive either psychological therapy or educational control. There are 10 appointments over 6 months. At these visits, Vital signs will be checked, blood and urine samples taken and questionnaires and psychology and memory tests will be done. 3 of the visits will involve ketamine or placebo infusion. Participants will also wear an ankle bracelet that measures alcohol usage for the trial duration. Prolonging abstinence in patients with alcohol dependency will improve their physical health, reduces life threating related diseases and lessens the financial burdens on the NHS. We believe this may be better achieved with a package of psychotherapy and Ketamine.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0312
Date of REC Opinion
4 Feb 2016
REC opinion
Further Information Favourable Opinion