People with severe alcohol disorder were able to abstain from drinking alcohol for longer when treated with low doses of ketamine combined with psychological therapy, a clinical trial has found.
The Ketamine for reduction of Alcohol Relapse (KARE) trial is the first of its kind to investigate whether a low dose of ketamine combined with therapy could help prevent heavy drinkers from relapsing after giving up alcohol. The trial followed preliminary evidence that controlled ketamine therapy can reduce the number of alcoholics who relapse. Currently, few effective treatments exist for severe alcoholism, which has a devastating impact on lives.
Published in The American Journal of Psychiatry, the study included 96 people with alcohol problems who were abstinent at the time of the trial. The team found that people who had ketamine combined with therapy stayed completely sober for 162 of 180 days in the six month follow-up period, representing 87 percent abstinence. This was significantly higher than any of the other groups, indicating that the therapy may also have promise for preventing relapse. This group was more than 2.5 times more likely to stay completely abstinent at the end of the trial than those on placebo.
The trial was led by the University of Exeter in collaboration with Imperial College London and University College London, and funded by the Medical Research Council. The study was conducted at the NIHR Exeter and NIHR UCLH Clinical Research Facilities.
The team also found some evidence that ketamine and therapy may prevent any drinking over six months, though the results were more mixed. Patients having ketamine also experienced less depression after three months, and better liver function than those on placebo, regardless of whether it was combined with therapy or not.
Lead author Professor Celia Morgan, of the University of Exeter, said: “Alcoholism can destroy lives, and we urgently need new ways to help people cut down. We found that controlled, low doses of ketamine combined with psychological therapy can help people stay off alcohol for longer than placebo. This is extremely encouraging, as we normally see three out of every four people returning to heavy drinking within six months of quitting alcohol, so this result represents a great improvement.”
Before the trial, participants were drinking every day, consuming 125 units in a week - the equivalent of 50 pints of strong beer. Participants given ketamine and therapy drank over the recommended guidelines on just five days in total over the six month trial period on average. This represents cutting the risk of death from alcohol-related illnesses from one in eight, to one in 80.
Professor Morgan added: “The number of alcohol-related deaths has doubled since the pandemic began, meaning new treatments are needed more urgently than ever. Previously, there were some concerns about using ketamine in alcoholics due to liver problems, but this study has shown that ketamine is safe and well-tolerated in clinical conditions. In fact, we found liver function improved in the ketamine group due to them drinking much less alcohol.
“This was a phase II clinical trial, meaning it’s conducted in people primarily to test how the safety and feasibility of the treatment. We now have an early signal this treatment is effective. We now need a bigger trial to see if we can confirm these effects.
“We’re certainly not advocating taking ketamine outside of a clinical context. Street drugs come with obvious risks, and it’s the combination of a low dose of ketamine and the right psychological therapy that is key, as is the expertise and support of clinical staff. This combination showed benefits still seen six months later, in a group of people for whom many existing treatments just don’t work.”