A recent phase II double-blind placebo-controlled study conducted by Awakn Life Sciences, a Canadian biotech company focused on solutions for addiction therapy, demonstrated strong evidence supporting Ketamine-assisted therapy as a highly effective treatment for severe Alcohol Use Disorder (AUD).
The trial included 96 patients with severe AUD who were randomly assigned to one of four groups:
Three ketamine infusions (0.8 mg/kg IV over 40 minutes) in conjunction with a proprietary manualized therapy titled "KARE"
Three saline infusions plus KARE therapy
Three ketamine infusions plus alcohol education
Three saline infusions plus alcohol education
To measure the effects of the treatments on AUD, researchers tracked the number of abstinence days in the following 6 months and the rate of relapse at the 6-month follow-up. Here is what they found:
Abstinence: Ketamine combined with KARE therapy resulted in total abstinence in 162 of 180 days following administration, amounting to 86% abstinence rate post-trial in comparison to 2% abstinence rates prior to the trial.
Relapse: At the 6-month follow-up point, the ketamine plus KARE therapy group demonstrated a 270% less chance of relapse in comparison to the alcohol education group.
“Alcohol Use Disorder is a 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 Prof. Morgan who led the research efforts. “We found that controlled, low doses of ketamine combined with manualized 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 twelve months of treatment. The data we’ve collected from this study paves the way for a paradigm shift in how AUD is treated”
The study also identified additional encouraging secondary outcomes that included:
Improved liver function across several different markers
Statistically significant decrease in depression after 3 months
Increase in the ability to experience pleasure
In addition to the primary and secondary outcomes, researchers were also able to identify significant reductions in heavy drinking days in the participants. The ketamine plus KARE therapy group reported an average of 12 heavy drinking days in the 180 days following administration which according to the researchers is "a large reduction compared to other trials in this area and it is widely believed the real-world data is far higher than this". The KARE therapy plus ketamine group also measured a significant risk in the risk of mortality; "1 in 8 patients would have died within 12 months without treatment, that number decreased to 1 in 80 following the treatment".
The trial demonstrated that 3 ketamine infusions supported alcohol abstinence, and the results were enhanced when combined with psychotherapy. No serious adverse events were reported during the trial. For the millions who suffer from AUD globally, treatment opportunities and options are lacking and many treatments prove ineffective in preventing relapse. Research studies such as this are laying the foundation for novel and effective treatments that could save millions of lives globally.