GREENWICH, Conn. , Oct. 31, 2024 /PRNewswire/ -- B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company dedicated to the development of psychedelic medicines for substance abuse disorders, is pleased to announce that its collaborator, Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, has been awarded a grant of $3 million per year for a total of 5 years dependent on progress during the first 2 years, from the National Institute of Drug Abuse (NIDA). This funding will support the first clinical trial to evaluate psilocybin's efficacy as a treatment for Opioid Use Disorder (OUD). If successful, the trial will provide the basis for a full-scale drug development program aimed at achieving FDA approval for psilocybin as a treatment for OUD.
The NIDA-funded, double-blind, multi-site, phase 2 randomized controlled clinical trial will assess psilocybin's therapeutic potential to reduce opioid cravings and improve emotional well-being in individuals struggling with OUD but who continue to use non-prescribed opioids despite adherence to methadone treatment. Conducted across four treatment centers in New York and New Mexico, the trial plans to enroll 240 participants, including OUD patients with co-occurring substance use and psychiatric disorders. With participants drawn predominantly from low-income minority populations, the study marks a significant shift toward diversity in psychedelic research, addressing a critical knowledge gap with respect to underrepresented groups.
Participants will receive manualized, non-directive clinical support and will be randomly assigned to receive a single administration of psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), or psilocybin 1 mg (low-dose control condition). Weekly urine drug screens and continuous self-report of opioid and other drug use will be collected for 24 weeks after psilocybin administration, along with measures probing OUD-related neuropsychopathology and functional outcomes.
Unlike previously reported psychedelic trials, the study will include prospective assessment of pre-randomized patient expectancies along with post-treatment patient beliefs regarding treatment assignment, providing data for modelling the contribution of expectancy effects on reported outcomes.
B.More, which will license the trial data for commercial development, will supply cGMP psilocybin for the study and will also fund other support for the goal of an eventual New Drug Application (NDA).
"This trial is a vital step toward understanding psilocybin's therapeutic potential in Opioid Use Disorder," said Carey Turnbull, Co-founder, and CEO of B.More Inc. "In working with Dr. Bogenschutz, our goal is to create a treatment pathway that's accessible, effective, and safe, opening new avenues for psychedelic-assisted therapy as an FDA-approved tool in the fight against addiction. This NIDA funded OUD trial taking place in substance abuse treatment centers pairs nicely with NYU's previously announced NIH funded alcohol use disorder trial being conducted within the Silver Hill rehab center, adding to their expertise in the treatment of substance abuse using psilocybin."
According to Dr. Bogenschutz, "In addition to providing a rigorous test of safety and efficacy, this trial will provide information regarding the feasibility of implementing psilocybin-assisted treatment for OUD within the existing system of care. If psilocybin is found to be safe and effective, this model would provide a new option for OUD patients who are receiving treatment but continue to struggle with illicit opioid use."
About B.More
Founded in 2017 by Carey and Claudia Turnbull, B.More is a 501(c)(3) non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for those struggling with alcohol use disorder and other substance use disorders. With researchers at the NYU Grossman School of Medicine, B.More is advancing clinical research to help these individuals, and their loved ones, live a better tomorrow.
For more information, please visit www.bmoreinc.org
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