Diamond Therapeutics Inc. (“Diamond”), a clinical-stage drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the enrollment of the first patient in an FDA-approved clinical trial conducted at the University of Alabama at Birmingham (UAB). The principal investigator is Dr. Peter S. Hendricks, a clinical psychologist and professor at UAB’s Health Behavior Department in the School of Public Health. This study is referred to as the UAB-Diamond Trial.
Dr. Hendricks has published nearly 100 peer-reviewed manuscripts with 3,504 citations. His work has been recognized in media outlets, including National Geographic, The Economist, Business Insider, New York Times, Newsweek, U.S. News & World Report, Scientific American, Vogue, and Michael Pollan’s bestseller, “How to Change Your Mind.” Dr. Hendricks was recently named the first editor-in-chief of the journal Psychedelic Medicine, published by Mary Ann Liebert, Inc. He has provided keynote addresses on the topic of psychedelics nationally and internationally, including at the FDA and several other leading institutions.
The UAB-Diamond Trial will enroll 60 patients to evaluate the treatment of low doses of psilocybin in demoralization, which involves feelings of hopelessness and meaninglessness. The trial will assess initial signals of efficacy, feasibility, and potential mechanisms of action. Psilocybin will be administered across a series of low doses that are not expected to produce hallucinogenic or other subjective effects, which may limit broad use.
Demoralization is believed to be pervasive in the wake of COVID-19, resulting in a widely experienced unmet need for treatment. “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,” notes Dr. Hendricks.
Dr. William J. Tyler serves as a scientific advisor and Chief Technical Officer to Diamond, as well as professor at UAB’s School of Engineering-Biomedical Engineering and head of the UAB’s Alabama BRAIN Lab, although he is not actively involved in the UAB-Diamond study. Dr. Tyler says, “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.”