Tel Aviv— Clearmind Medicine Inc., a trailblazer in psychedelic drug development, has announced a significant milestone in its journey to address Alcohol Use Disorder (AUD). The company has entered into a Clinical Trial Agreement with the esteemed Johns Hopkins University School of Medicine to conduct a Phase I/IIa clinical trial of its novel MEAI-based drug, CMND-100.
This groundbreaking clinical trial, dubbed CM-CMND-001, is a multinational, multi-center study designed to evaluate the tolerability, safety, and pharmacokinetics of CMND-100. The trial will involve healthy volunteers as well as individuals diagnosed with AUD, marking a crucial step in understanding and potentially revolutionizing the treatment of this pervasive condition.
AUD, a widespread issue characterized by an individual’s inability to control alcohol consumption despite its negative impact on health, social, and occupational spheres, remains a significant public health challenge. Clearmind’s CMND-100, administered orally in capsule form over a ten-day period, aims to address this challenge head-on. The trial will closely monitor participants’ drinking patterns, alcohol and cigarette cravings, and depression symptoms, offering comprehensive insights into the treatment’s efficacy.
Johns Hopkins University School of Medicine has emerged as the second U.S.-based medical site to participate in Clearmind’s clinical trial, following the Yale School of Medicine’s Department of Psychiatry. This collaboration underscores the growing interest and investment in psychedelic drug research, particularly for neuropsychiatric conditions.
The primary goal of the CM-CMND-001 trial is to determine the tolerable dose of CMND-100 and to characterize its safety and pharmacokinetics/pharmacodynamics (PK/PD) in both healthy subjects and those with AUD. A secondary, yet equally vital, endpoint is to evaluate the drug’s efficacy in reducing drinking patterns and cravings in individuals with moderate-to-severe AUD. Additionally, the trial will explore the impact of CMND-100 on depression symptoms, offering a holistic view of its potential therapeutic benefits.
This partnership between Clearmind Medicine and two of the world’s leading medical research institutions represents a significant leap forward in the exploration of psychedelic drugs as viable treatments for neuropsychiatric disorders. As the trial progresses, it holds the promise of not only advancing scientific understanding but also offering new hope to those grappling with the challenges of Alcohol Use Disorder.
