Diamond Therapeutics has announced that the first patient has been enrolled in its FDA-authorised UAB-Diamond trial evaluating low-dose psilocybin in patients with demoralization.
The trial is enrolling 60 patients and will evaluate the treatment of microdoses psilocybin in demoralization, which involves feelings of hopelessness and meaninglessness.
Demoralization is believed to be pervasive in the wake of COVID-19, resulting in a widely experienced unmet need for treatment. The trial is being conducted at the University of Alabama at Birmingham (UAB).
“This study is significant because it is the first to test low doses of psilocybin in the treatment of demoralization and is also among the first to test the effectiveness of low doses of psilocybin in a clinical rather than a healthy sample group,” noted lead researcher Dr Peter Hendricks, clinical psychologist and professor at UAB’s Health Behavior Department in the School of Public Health
The psilocybin microdoses, which are not expected to induce hallucinations, will be administered periodically and the trial will assess efficacy, feasibility, and potential mechanisms of action.
Dr William Tyler, scientific advisor and Chief Technical Officer at Diamond, and professor at UAB’s School of Engineering-Biomedical Engineering and head of the UAB’s Alabama BRAIN Lab, although not actively involved in the UAB-Diamond study, added: “Diamond has achieved many notable milestones, including cellular studies, animal studies, and studies with healthy humans.
“Commencing the UAB-Diamond Trial is a landmark moment for Diamond and for the future of psychedelic medicine.
“The research community is keen to understand low-dose psilocybin’s impact on a clinical population. It is our sincere hope that these efforts will help provide solutions to the mental health crises facing our nation.”
