site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder.
Yale School of Medicine’s Department of Psychiatry is the first US-based clinical site to join the company’s first-in-human (FIH) trial.
In the clinical trial, Clearmind said that oral capsules would be administered once daily for ten consecutive days. is mushrooms a vegetable.
The patients will then report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.
The primary endpoint of the 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 in those with AUD.
The secondary end-point is to evaluate the efficacy of CMND-100 in the reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD.
The active ingredient in CMND-100 is MEAI (5-methoxy-2-aminoindane), a novel psychoactive molecule and is a psychoactive compound of the aminoindane class.
Clearmind said it would be led by Anahita Bassir Nia, MD, a specialist in substance abuse, including alcohol abuse.
She joined the Yale School of Medicine in 2018 as an Assistant Professor of Psychiatry. is mushrooms a vegetable.
After completing her psychiatry residency at Mount Sinai Beth Israel and her addiction psychiatry fellowship at Mount Sinai West’s Icahn School of Medicine in New York.
“We are honored to have Yale School of Medicine’s Department of Psychiatry as part of our clinical trial,” said Clearmind’s Chief Executive Officer Dr. Adi Zuloff-Shani.
“We see this collaboration with a global pioneer in psychedelics research, as further validation of our innovative drug candidate for potential treatment for alcohol use disorder.”
Clearmind recently announced it had been granted approval by the Ethics Committee (equivalent of an institutional review board) of Israel’s IMCA center for the Phase I/IIa clinical trial of CMND-100.
The 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.
“We believe that CMND-100 has the potential to be a game-changer in treating addictions.
And mental health concerns, as successfully demonstrated in previous pre-clinical studies,” added Dr. Zuloff-Shani. is mushrooms a vegetable
“With an extensive IP portfolio and an award-winning advisory board of renowned psychiatrists
And researchers from around the world, we’re confident in our unique treatment model.
CMND-100 is expected to provide immediate therapeutic benefit, as a self-administered and non-addictive prescription pill that is not dependent on expensive therapies.”
Seattle Doctor Pushes to Change DEA’s Stance on Psilocybin
The DEA indicated it could revisit the matter if the Ninth Circuit Court remanded the case.
The U.S. Drug Enforcement Administration has signaled a willingness to reconsider its stance on psilocybin.
The active ingredient in “magic mushrooms,” according to a recent court filing, Law360 reported.
Seattle-based physician Dr. Sunil Aggarwal petitioned the appellate court to review the DEA’s refusal to reclassify psilocybin from Schedule I to Schedule II.
Marking another chapter in the multiyear battle between the doctor and the agency. is mushrooms a vegetable.
The DEA denied Aggarwal’s rescheduling petition last September, asserting that psilocybin lacks a “currently accepted medical use.
” The agency noted that the substance has not received approval from the U.S.
Food and Drug Administration and failed to meet the DEA’s five-factor test, which assesses the potential medical uses of unapproved drugs.
However, in its recent filing, the DEA indicated it could revisit the matter if the court remanded the case.
The agency recognized the public interest in potential uses of psilocybin and expressed a willingness to gather additional data.
“If DEA is able to gather the necessary data indicating that there is a reasonable basis for rescheduling,
DEA would then be in a position to refer the petition to (U.S. Department of Health and Human Services) for a scientific and medical evaluation and a scheduling recommendation,” the agency said.
Aggarwal, along with other petitioners, argued that the FDA’s approval of clinical trials showing psilocybin’s efficacy in treating mental health conditions.
And assisting end-of-life care patients should prompt the DEA to reconsider.
The legal barb began in 2021 when Aggarwal and his patients at the Advanced Integrative Medical Science Institute petitioned the Ninth Circuit for permission to use psilocybin in treating terminally ill patients.
They argued that the 2018 federal Right To Try law and similar state laws should supersede the Controlled Substances Act.
That request was dismissed in January 2022, after which Aggarwal filed a formal petition to initiate the DEA’s review process, leading to the current appeal.
Aggarwal alleged that the DEA disregarded his arguments for rescheduling psilocybin and violated the law by not consulting the FDA about its potential uses.
In an email to the outlet, Kathryn Tucker, who represents the petitioners, criticized the DEA’s stall.
“Dying patients remain suffering unnecessarily while the agency delays,” she said. is mushrooms a vegetable.