Researchers randomly allocated people to one of four treatment arms, to explore the combined use of low-dose ketamine and psychotherapy as a treatment for alcoholism.
A newly-signed agreement between the University of Exeter, Devon Partnership NHS Trust and Awakn Life Sciences lays down the foundations for assessing NHS readiness for ketamine-assisted psychotherapy.
The new Memorandum of Understanding (MOU) brings together cutting-edge researchers at the University with the NHS trust that provides local addiction services, and Awakn Life Sciences Corp, a biotechnology company developing and delivering psychedelic medicines and therapies to treat Addiction.
The partnership establishes a framework and strategic relationship to assess NHS organisational readiness for ketamine-assisted psychotherapy.
It will investigate how to enhance the evidence base for ketamine-assisted psychotherapy as an alternative treatment for depression patients who have not responded to treatment, and Alcohol Use Disorder within the NHS.
The partnership will also assess how best to accelerate approval for the use of ketamine-assisted psychotherapy to treat Alcohol Use Disorder at scale.
One of the projects in the scope of the MOU is to progress the phase II KARE (Ketamine for reduction of Alcohol Relapse) study forward into a pivotal phase III trial.
Led by the University of Exeter, the trial is soon to be published in the American Journal of Psychiatry.
Researchers randomly allocated people to one of four treatment arms, to explore the combined use of low-dose ketamine and psychotherapy as a treatment for alcoholism.
The method of use for ketamine developed in this trial, which Awakn have exclusively licensed, has strongly indicated in a clinical trial to be more effective at treating Alcohol Use Disorder than any other currently available treatments.
The new MOU will create the framework for the three partners to assess how best to bring this research forward into a planned three-armed, phase III pivotal trial in the UK, with one arm of the trial being designed to test the relative efficacy of digital/remote delivery of therapy.
Professor Celia Morgan, of the University of Exeter, who leads the KARE trial, said: "The signing of this Memorandum of Understanding, with Devon Partnership NHS Trust and Awakn, marks the beginning of a journey in building awareness of the efficacy and sustainability of ketamine-assisted therapies.
"At the University of Exeter, we're leading the way in clinical trials of combined psychological and pharmacological interventions, with experience of novel compounds such as MDMA and ketamine.
"We're passionate about working with external organisations, recognising that through collaboration, we can strengthen our research, and broaden and deepen its impact."
Anthony Tennyson, Awakn's chief executive officer, said: "The signing of the MOU is an important milestone as mental health issues continue to escalate globally.
"As we push towards our goal of delivering this novel treatment to patients across the UK, Europe and the world, we are excited to lay the groundwork with Devon Partnership NHS Trust and the University of Exeter, to increase access for psychedelics to treat addiction and more.
"By collaborating, Awakn can further accelerate the development and delivery of psychedelic therapeutics for those in need of alternative treatments from the current standard of care.
"We are making strides towards ketamine-assisted therapies being adopted into mainstream clinical use."
Tobit Emmens, Research Director at Devon Partnership Trust (DPT), said: "We're really excited about this opportunity to work with Awakn Life Sciences and the University of Exeter.
"As a research-active Mental Health NHS Trust this is a really positive step forward to improving treatment options for people with addictions, and for those with treatment-resistant depression."
DPT provides a wide range of NHS services to people with mental health, learning disability and autism needs across Devon, the wider South West region and nationally. DPT is passionate about promoting good mental health and wellbeing and strives to use the expertise and resources within its organisation, and through its partnerships, to deliver high quality services that are safe and focused on people's recovery.
