Researchers from the University of Exeter in the UK partnered with biotech company AWAKN Life Sciences to conduct a Phase II clinical trial to discover if low doses of ketamine could help alcohol users remain sober. To conduct the study, researchers recruited 96 people who had previously been drinking every day, but were attempting to quit.
The subject pool was divided into four groups. One group received low intravenous doses of ketamine combined with KARE, a proprietary therapy program developed by the University of Exeter. A second group participated in the same therapy sessions, but received a placebo dose of saline instead of ketamine. The third group received ketamine infusions along with a standard course of alcohol education, and the fourth received a placebo with the alcohol education.
The subjects who received ketamine with the KARE therapy sessions were able to stay sober for an average of 162 days out of the 180-day trial period. This degree of abstinence reduced these subjects' chances of dying from alcohol-related health issues to 1 in 8, down from 1 in 80 for those who continue to drink daily. At the end of the trial, the risk of relapse for the ketamine-assisted therapy group was 2.5 times lower than the group that received the placebo.
“Alcoholism can destroy lives, and we urgently need new ways to help people cut down,” said lead author Professor Celia Morgan in a statement. “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.”
In addition to cutting back on drinking, subjects who received the ketamine therapy reported a significant reduction in symptoms of depression. These findings support dozens of other clinical research studies confirming that low doses of ketamine can help fight treatment-resistant depression. In the US, federal health officials have even approved a ketamine nasal spray for patients with severe depression.
In a separate study, researchers interviewed 12 of the subjects who were able to quit drinking after participating in the ketamine-assisted therapy group. Many of the participants said that the combined treatment helped them think less about their own problems and feel more connected with the world. Other research studies have also found that other psychedelics, like LSD and psilocybin, can also help people overcome addiction and mental health issues by boosting psychological flexibility and helping the brain grow new neural connections.
“The experiences people describe after taking ketamine infusions suggest the drug gives a new perspective that may be helpful in psychological therapy,” said lead author Merve Mollaahmetoglu, of the University of Exeter. “Ketamine induces a sense of being outside of your body that some say can stimulate an ‘observer state’ similar to that described in mindfulness, which may help patients take a step back, and consider thoughts and emotions. Participants told us this experience helped change their relationship with alcohol.”
The researchers conducted this initial Phase II trial on a smaller scale due to concerns over subjects' liver health. Like alcohol, regular ketamine use can cause liver damage, and the combined use of the two drugs could potentially amplify these effects. However, researchers found that subjects in the ketamine-assisted therapy group actually had better liver function than other subjects, likely due to the fact that they were consuming significantly lower quantities of alcohol.
“The number of alcohol-related deaths has doubled since the pandemic begun, meaning new treatments are needed more urgently than ever,” Dr. Morgan explained. “This was a phase II clinical trial, meaning it’s conducted in people primarily to test… 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.”
Following these successful results, the study authors will advance to a much larger Phase III study. And if this trial is successful, it could convince the UK government to fully legalize ketamine-assisted therapy for alcohol abuse. Meanwhile, the University of Exeter and AWAKN are also partnering on another study to discover whether ketamine can help treat people who are struggling with gambling addiction.