MDMA-Assisted Psychotherapy: Awakn, led by Anthony Tennyson, George Scorsis, Dr. Ben Sessa, moves forward with Phase II Study

Researchers behind United Kingdom-based Awakn Life Sciences Inc. believe that the use of psychedelics combined with psychotherapy is the next evolution in psychiatric treatment. They are now one step closer to achieving their mission to incorporate these methods into mainstream care in the UK and European Union.

According to a company press release, Awakn has selected contract research organization ('CRO'), PRA Health Sciences (NASDAQ: PRAH), to conduct a Phase IIb trial studying the effectiveness of MDMA-Assisted Psychotherapy as a treatment for patients with Non-Physically Dependent Alcohol Use Disorder.

The study, which will be conducted in the UK, will be a double-blind, placebo-controlled clinical trial designed to investigate the safety and efficacy of MDMA as a pharmacological treatment for Alcohol Use Disorder.

There has been growing evidence that MDMA is useful in the treatment of alcohol addiction. Chief Medical Officer, Dr. Ben Sessa, who will head the Phase II clinical trial, previously published his research on the matter in the journal, Neuropharmacology.

Dr. Ben Sessa stated: "MDMA-Assisted Psychotherapy, as evidenced from our world's-first pilot study on the subject, is well-placed to help patients with AUD tackle rigidly held narratives surrounding their history of trauma that maintains their harmful drinking. I am pleased that we at Awakn are spear-heading the global initiative to develop new efficacious strategies for tackling this condition. Our patients deserve the best that cutting-edge psychopharmacology research can offer."

The Phase II trial is just the latest in a string of research studies being conducted on the use of psychedelics to treat patients with mental illness or addiction.

In late December, the Medicines and Healthcare products Regulatory Agency (MHRA) approved a clinical trial that will allow researchers to explore the potential of dimethyltryptamine (DMT) as a treatment for mental health disorders such as depression. DMT, a main ingredient of ayahuasca, is a Class A drug in the UK and has a similar impact to other psychedelic drugs but lasts a much shorter time.

According to Carol Routledge, chief scientific and medical officer at Small Pharma, “We think this could be a treatment for a number of depressive disorders besides major depression, including PTSD, treatment-resistant depression, obsessive-compulsive disorder, and possibly some types of substance abuse.”

In further developments, Awakn will be opening UK’s first medical psychedelic clinic in February, located in Bristol. In this clinic, ketamine-assisted psychotherapy is implemented or a series of low doses of ketamine complemented by talk therapy sessions. Legal in the UK, ketamine is most commonly used as an anaesthetic.

The news of the MDMA study aligns with Awakn’s recent launch of its Commercial Clinical Research Division, which will sponsor and deliver clinical trials for commercial and not for profit organizations across Europe and North America. Awakn is led by scientists and drug policy reform advocates, as well as a dedicated corporate board.

Awakn is looking to open a chain of similar clinics in cities like London, Birmingham, Manchester and Brighton.

“The potential for psychedelic medical treatment in the UK is looking very promising, with AUD being one of the most prevalent substance use disorders. This initiative led by Dr. Ben Sessa will demonstrate the efficacy of MDMA as a treatment for AUD,” says George Scorsis, Chairman of Awakn.

The clinical trials will offer psychedelic drug treatments for a myriad of mental health conditions such as post-traumatic stress disorder (PTSD), anxiety, depression, and addiction.

At a time when the COVID-19 pandemic has created the potential for a global mental health crisis, psychedelic medicines could offer a reprieve from symptoms.

“In recent months, pandemic-related depression, anxiety and alcohol consumption have significantly worsened due to COVID-related lockdowns. The need for research and advances in this area is even more prevalent than it has ever been,” George Scorsis notes.

The research division launch comes at a time when interest in the use of psychedelic medicines is gaining attention around the world.

In London, for instance, mental healthcare company COMPASS has set up a large clinical trial to assess the potential of psilocybin in the treatment of depression.

Tracy Yeung, Chief Communications Officer at COMPASS Pathways, says: “We’re generating the evidence that can be used to get into national health systems. At the moment, we’re in the stage of rigorous clinical trials to show that this treatment works, to give people the confidence to eventually use them as [a] clinical therapy.”

Around the world, the use of psychedelics as a treatment option is beginning to gain followers.

In November 2020, Oregon voted to legalize the therapeutic use of psilocybin. And in Canada, psilocybin was approved for terminally ill patients. Elsewhere, the possession of psilocybin has been decriminalised in Portugal, Spain, the Czech Republic, and Austria.

In 2018, medical cannabis was legalized by the government, but few patients have been able to access it or have had to rely on private clinics.

With a portion of the population in the UK and Europe suffering from mental health-related illnesses, the hope is that Awakn will be able to make a significant impact on lowering those statistics by helping the medical community learn how many conditions can be treated by psychedelics.

This article does not necessarily reflect the opinions of the editors or management of EconoTimes