Clearmind Medicine Receives IRB Approval To Begin Phase 1/2a Clinical Trial For Alcohol Use Disorder At Hadassah Medical Center

‍Clearmind Medicine Inc., a clinical-stage biotechnology company developing novel psychedelic-based treatments for major unmet medical needs, has received Institutional Review Board (IRB) approval from Hadassah Medical Center in Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial of CMND-100. This proprietary, MEAI-based oral drug candidate is being investigated for its potential in treating Alcohol Use Disorder (AUD). With this approval, the company can now begin patient enrollment at Hadassah Medical Center, one of Israel’s leading clinical institutions, marking an important milestone before initiating the trial at the site.

The Phase 1/2a clinical trial is a multinational and multi-center study aimed at evaluating the safety, tolerability, and pharmacokinetic profile of CMND-100. It will also examine early signs of the drug’s effectiveness in reducing alcohol cravings and consumption in patients diagnosed with AUD. In addition to Hadassah Medical Center, the study includes other renowned institutions such as Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine, and Tel Aviv Sourasky Medical Center. At the Hadassah site, the trial will be led by Professor Joseph Caraco, Director of the Clinical Pharmacology Unit in the Department of Medicine.

Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, stated, “Securing IRB approval from Hadassah-University Medical Center, a globally respected institution, marks another important step in our journey to address the deep unmet need in Alcohol Use Disorder. The addition of Hadassah to our growing network of top-tier research centers including Yale and Johns Hopkins reflects the strong momentum behind our clinical program and reinforces our commitment to pioneering next-generation psychedelic-based therapies that can truly change lives.”

The IRB approval from Hadassah follows earlier regulatory achievements by Clearmind, including approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) and IRB clearances at other clinical sites involved in the study. Alcohol Use Disorder remains a serious global health issue, contributing to approximately 4.7% of all deaths worldwide, according to the World Health Organization. With this clinical trial, Clearmind aims to advance a potentially transformative treatment for individuals and families impacted by AUD. The company expects to continue making progress in patient enrollment and data collection across its clinical trial sites.