Awakn intends to run a Phase III trial for ‘Ketamine-Assisted Psychotherapy for Alcohol Use Disorder’
Awakn announced today an exclusive license to use and deliver the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention, as validated in a Phase II clinical trial led by the University of Exeter.
The KARE clinical research study, led by Prof. Celia Morgan of the University of Exeter, was a Phase II a/b, four-armed, placebo-controlled trial assessing ketamine combined with the KARE psychotherapy in the treatment for alcohol use disorder (AUD). The study started in 2016, finished in 2020 and included 96 participants, funded by the Medical Research Council. The primary endpoints of the Phase II trial were percentage days abstinent and relapse at 6 months, with secondary endpoints including depressive symptoms, craving, and quality of life.
The combined therapy arm, compared to other arms, demonstrated a clear capacity to improve the lives of people struggling with alcohol problems by reducing drinking over a six-month period.
Awakn also today announced that Prof. Celia Morgan will support Awakn’s activity in bringing the KARE research forward form Phase II to Phase III (subject to regulatory approval) and introducing evidence-based Ketamine-Assisted Psychotherapy for AUD into Awakn’s clinics as they open throughout the UK and EU.
Prof. Celia Morgan stated “It is a great milestone in Ketamine-Assisted Psychotherapy to take this novel evidence-based treatment forward both into the clinic and to a fully definitive Phase III trial. The Phase III study of Ketamine-Assisted Psychological therapy would be a world first in any patient group, and the first Phase III trial of ketamine in Alcohol Use Disorder.”
Dr. Ben Sessa, Awakn Chief Medical Officer, who recently announced results of the world’s first ‘MDMA in Alcohol Use Disorder’ clinical trial stated “Psychotherapy forms the bedrock of the way we use ketamine at Awakn, Celia Morgan’s cutting-edge research is the world's first evidence-based approach combining ketamine with psychotherapy to treat Alcohol Use Disorder. In this post-COVID era there is no better time to be bringing this effective treatment approach to our patients struggling with alcohol use disorder."