Awakn Life Sciences has announced plans to conduct a Phase IIb trial to study MDMA-assisted psychotherapy as a treatment for patients with alcohol use disorder, with PRA Health Sciences as the contract research organization for the project.
The study, which will take place in the United Kingdom, will be a double-blind, placebo-controlled clinical trial, Awakn said in a news release. Ben Sessa, MBBS (MD), MRCPsych, the organization’s chief medical officer, will serve as principal investigator. Previously, Sessa led a pilot study on the use of MDMA-assisted psychotherapy for treating alcohol use disorder.
The prevalence of AUD, and the poor outcomes from contemporary psychiatry at treating this significant public health problem, have always been worrying,” Sessa said in a statement. “This situation has significantly worsened during COVID. With drinking habits increasing during lock-down, we are now facing a significant increase in mental disorders and addictions to all substances, of which AUD is by far the most concerning.
“Now is the time for innovative, safe, and effective approaches to tackle AUD. 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. “
Based in Toronto, Awakn Life Sciences is a biotech firm that focuses on research, development and delivery of psychedelic medicines for the treatment of conditions that include addiction, anxiety, depression and PTSD. PRA Health Sciences is a global contract research organization that provides outsourced clinical development and data solution services. The firm operates 75 offices worldwide.