Ketamine-assisted therapy for alcohol addiction could save lives

The world’s first controlled study exploring the use of ketamine-assisted psychotherapy for the treatment of alcohol use disorder (AUD) has shown positive results.

Results from the Awakn Life Sciences’ Phase IIa/b study investigating ketamine-assisted therapy for the treatment of AUD has shown 86 per cent abstinence for six months following treatment. The therapy has the potential to save lives, according to the study’s lead researcher.

The primary and secondary endpoints of the double-blind placebo-controlled clinical trial, which included 96 patients with severe AUD, were days abstinent and relapse at six-month follow-up.

Results from the study have been published in the American Journal of Psychiatry.

“Alcohol Use Disorder is pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post-treatment tend to be high. We urgently need new and more effective treatments,” said psychopharmacology professor Celia Morgan, who led the trial conducted by the University of Exeter.

The findings demonstrated that ketamine combined with proprietary manualised therapy (KARE) therapy, resulted in total abstinence in 162 of 180 days in the following six-month period. This was an increase in abstinence from around 2 per cent prior to the trial to 86 per cent post-trial.

The results for relapse at six months showed that the Ketamine plus KARE group’s risk of relapse was 2.67 times less than the placebo plus alcohol education group.

Morgan, who is also Awakn’s head of ketamine-assisted therapy for addiction, added: “We found that controlled, low doses of ketamine combined with manualised psychological therapy can significantly increase post-treatment abstinence rates.

“This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within six months of treatment. With the data we’ve collected from this study, along with emerging data from other studies of ketamine to treat AUD, they strongly suggest that further trials of this treatment are warranted.”

Participants in the trial were randomised into four groups. The first, three ketamine infusions plus KARE; the second, three saline infusions plus KARE; the third, three ketamine infusions plus alcohol education; and the fourth, three saline infusions plus alcohol education.

The secondary outcomes of the study also identified encouraging results including improved liver function across several different markers, a statistically significant decrease in depression after three months and a decrease in anhedonia, which is the inability to experience pleasure.

Morgan identified further significant results in the reduction in heavy drinking days.

At six months post-trial, there were only 12 heavy drinking days in the ketamine plus KARE group – a steep reduction compared to other trials in this area. For example, a US study of detoxified alcoholics in outpatient alcohol treatment reported 52 heavy drinking days at the same six-month marker and it is widely believed the real-world data is far higher than this.

There was also a 10-fold decrease in the risk of mortality; one in eight patients would have died within 12 months without treatment, a number which decreased to one in 80 following the treatment.

In total, the trial demonstrated that three subanaesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy.

Anthony Tennyson, Awakn’s chief executive, commented: “We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them.

“We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry.”

Awakn has acquired the intellectual property to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally.

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