07 September 2023 | Thursday | News
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The principal investigator, Jennifer Ellis, PhD, Associate Professor of Psychiatry and Behavioral Sciences, JHU School of Medicine will be supported by co-investigators Professor Eric Strain, Director, Behavioral Pharmacology Research Unit, JHU School of Medicine.
"We are honored to collaborate with JHU for our first in human clinical trial. JHU is one of the global leaders in psychedelics clinical research and in researching addictions, and we are very grateful to partner with them to study our proprietary CMND-100 to treat Alcohol Use Disorder," said Clearmind’s Chief Executive Officer Dr. Adi Zuloff-Shani. "Johns Hopkins is our second US clinical site joining our trial, following Yale School of Medicine’s Department of Psychiatry. We are excited to be working closely with two of the world’s leading medical centers, who have researched our treatment and agreed to participate in our clinical program."
The potential of psychedelic drugs to treat various neuropsychiatric indications is currently being explored in several human clinical trials. Clearmind’s phase I/IIa trial, CM-CMND-001, the primary end point of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with Alcohol Use Disorder ("AUD"). The secondary end point is to evaluate the efficacy of CMND-100 in reduction of drinking patterns and cravings, in individuals with moderate-to-severe AUD. Oral capsules will be administered once daily, for ten consecutive days. The patients will report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.
CM-CMND-001 clinical trial is a multinational, multi-center, Phase I/II single- and multiple-dose tolerability, safety and pharmacokinetic study in healthy volunteers and AUD subjects.
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