Groundbreaking Study on Ketamine-Assisted Therapy for Alcohol Use Disorder

Introduction

Alcohol use disorder (AUD) is a significant public health issue, affecting millions of adults worldwide, including in the United States. Despite the widespread nature of this problem, only about 20% of those with alcohol issues receive treatment, and the success rate for long-term sobriety remains low. Approximately 75% of individuals who quit drinking relapse within a year. The consequences of AUD extend beyond the individual, impacting families, communities, and society at large. The financial burden on healthcare systems is substantial, with costs estimated in the billions. In response to this pressing issue, researchers in the United Kingdom are conducting the MORE-KARE study to explore the potential of ketamine-assisted psychological therapy to improve treatment outcomes for individuals with severe alcohol use disorder.

Background

Recent research has shown promising results for ketamine as a treatment for depression, and it may hold similar potential for AUD, especially when combined with psychological therapy. In an earlier trial conducted in the UK involving 96 participants with severe alcohol problems, three doses of ketamine administered intravenously, along with seven sessions of psychological therapy, were found to reduce alcohol consumption six months after treatment compared to a placebo. Notably, the combination of ketamine and therapy was more effective in reducing drinking than ketamine alone.

Building on these findings, the MORE-KARE study will expand this approach across multiple sites in the UK and a broader patient population. The study will involve 280 participants with severe AUD, randomly assigned to one of two groups: one receiving therapeutic doses of ketamine combined with psychological therapy, and the other receiving a very low dose of ketamine along with educational sessions on the harmful effects of alcohol.

Study Objectives

The primary goal of the MORE-KARE study is to determine whether the combination of ketamine and psychological therapy can reduce the number of heavy drinking days six months after the start of treatment. The study will also investigate whether short-term reductions in depressive symptoms, which are common among those with AUD, can predict long-term reductions in alcohol consumption. This dual focus on alcohol use and depression is particularly important, as depression often contributes to relapse in those who have quit drinking.

Methodology

Participants in the study will be divided into two groups. The first group will receive a therapeutic dose of ketamine (0.8 mg/kg) along with a structured psychological therapy known as KARE. The second group will receive a sub-therapeutic dose of ketamine (0.05 mg/kg) and a seven-session educational program about alcohol. The study will measure the number of heavy drinking days, changes in depressive symptoms, and other outcomes such as social and role functioning over a six-month period.

To track drinking behavior, participants will use a drink diary app and a breathalyzer, while depressive symptoms will be monitored using standard scales and advanced language analysis techniques. This innovative approach allows researchers to detect subtle changes in language that may indicate shifts in mood and predict future alcohol use.

Impact and Future Directions

If the MORE-KARE study demonstrates that ketamine-assisted therapy is effective, it could pave the way for a new treatment option to be made available within the UK’s National Health Service (NHS) and potentially influence treatment approaches in other countries, including the United States. This would represent a significant advancement in the management of AUD, offering hope to those who have struggled with conventional treatment approaches.

The study's findings will be shared through various channels, including high-impact academic publications, national workshops, and a stakeholder conference. Additionally, the research team will collaborate with patient and public involvement (PPI) representatives to develop training materials, clinical recommendations, and a web platform to support the implementation of this new treatment approach.

The MORE-KARE study, funded by the National Institute for Health and Care Research (NIHR) in the UK and industry partner Awakn Life Sciences, has the potential to make a lasting impact on the treatment of alcohol use disorder, improving outcomes for patients and reducing the burden on society.

Conclusion

Alcohol use disorder remains a significant challenge for individuals, families, and healthcare systems around the world, including the United States. The MORE-KARE study, conducted in the UK, represents a major step forward in addressing this issue by exploring the potential of ketamine-assisted psychological therapy to reduce heavy drinking and improve mental health outcomes. With the potential to transform the treatment landscape for AUD, this study could bring much-needed hope to those affected by this pervasive condition, both in the UK and beyond.