Johns Hopkins University School of Medicine (JHU) and Clearmind Medicine will be collaborating on research to investigate the use of a novel psychoactive molecule to treat Alcohol Use Disorder (AUD).
Clearmind has entered into a Clinical Trial Agreement with JHU to conduct its Phase 1/2a clinical trial of its proprietary MEAI-based CMND-100 – a novel psychoactive molecule.
According to Clearmind, CMND-100 has been reported to reduce the desire to consume alcohol while exerting a euphoric alcohol-like experience, and has been found to interact with the serotonergic receptors 5-HT1a, 5-HT2a and 5-HT2b.
On its website, the company states: “The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C and the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT); these are believed to participate in mediating alcohol drinking behaviour, and therefore could constitute important molecular targets for interventions that target drugs of abuse such as alcohol.”
This CM-CMND-001 clinical trial will be a multinational, multi-center, Phase I/II single- and multiple-dose tolerability, safety and pharmacokinetic study in healthy volunteers and AUD subjects.
Clearmind CEO, Dr Adi Zuloff-Shani, stated: ”We are honoured 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.
“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 centres, who have researched our treatment and agreed to participate in our clinical programme.”
The primary end point of the trial is to find the tolerable dose and characterise the safety and pharmacokinetics/pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with Alcohol Use Disorder.
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.
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.
