Clearmind Medicine has received Institutional Review Board (IRB) approval from Hadassah Medical Center in Jerusalem for its ongoing Phase 1/2a trial of CMND-100, an oral MEAI-based drug candidate for Alcohol Use Disorder (AUD). This approval allows patient enrollment at Hadassah, adding to existing sites like Yale, Johns Hopkins, and Tel Aviv Sourasky Medical Center.
This IRB approval follows FDA IND clearance and prior IRB approvals, signifying forward momentum for Clearmind’s AUD program. The inclusion of multiple prestigious institutions in the trial network underscores growing interest in psychedelic-derived therapeutics for addiction treatment. Leading the study at Hadassah is Prof. Joseph Caraco, Director of the Clinical Pharmacology Unit.
The trial’s multinational, multi-center design reflects the global prevalence of AUD and the need for diverse patient populations in clinical research. Clearmind’s strategic focus on AUD positions it within a growing field of companies exploring psychedelic-based treatments for mental health and addiction disorders. This approach, however, carries inherent risks related to the regulatory landscape and public perception of psychedelics.
This latest approval impacts multiple stakeholders. For research sites, it offers an opportunity to participate in a novel therapeutic area. Sponsors like Clearmind gain access to a wider pool of patients and expertise, accelerating data collection. The trial’s progress is also relevant to regulators, providing valuable real-world data on the safety and efficacy of psychedelic-based treatments, which could influence future policy decisions.
Looking ahead, the trial’s outcome will be crucial not only for CMND-100’s development but also for the broader field of psychedelic medicine. Success could attract further investment and accelerate research in this area, while setbacks could dampen enthusiasm and lead to stricter regulatory scrutiny. The key questions revolve around replicating positive early signals in larger and more diverse populations and managing the unique challenges associated with psychedelic therapies, including patient selection, setting, and integration of treatment into existing healthcare systems. The interplay between clinical evidence, regulatory pathways, and societal acceptance will ultimately determine the future of this emerging field.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
