Dr. Michael Bogenschutz Receives $15M NIDA Grant for Psilocybin Study in Opioid Use Disorder

B.More Inc., a non-profit clinical-stage biopharmaceutical company based in Greenwich, Connecticut, has announced an important development in its mission to combat substance abuse disorders. Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine and a collaborator with B.More Inc., has received a substantial grant from the National Institute of Drug Abuse (NIDA). This grant, amounting to $3 million annually for up to five years, will fund the first clinical trial to evaluate psilocybin's effectiveness as a treatment for Opioid Use Disorder (OUD).

This phase 2 double-blind, multi-site, randomized controlled trial aims to investigate the therapeutic potential of psilocybin in reducing opioid cravings and enhancing emotional well-being in individuals who continue to use non-prescribed opioids despite being on methadone treatment. The trial, spanning four treatment centers in New York and New Mexico, seeks to enroll 240 participants. These participants will include OUD patients who also struggle with co-occurring substance use and psychiatric disorders, predominantly from low-income minority populations. This focus on diversity represents a significant advancement in psychedelic research, addressing a critical gap in the study of underrepresented groups.

Participants in the study will receive non-directive clinical support and will be randomly assigned to one of three groups: a high dose of psilocybin (30 mg), a medium dose (20 mg), or a low-dose control condition (1 mg). Over a period of 24 weeks following the administration of psilocybin, weekly urine drug screens and continuous self-reports of opioid and other drug use will be collected. Additionally, the study will measure neuropsychopathology related to OUD and functional outcomes in the participants.

A unique aspect of this trial is the inclusion of a prospective assessment of patient expectancies prior to randomization, along with post-treatment beliefs regarding their treatment assignment. This approach aims to provide valuable data on the impact of expectancy effects on the reported outcomes.

B.More Inc., which will license the trial data for commercial development, is supplying cGMP psilocybin for the study and funding additional support to achieve an eventual New Drug Application (NDA). Carey Turnbull, Co-founder, and CEO of B.More Inc., emphasized the importance of the trial, stating, "This trial is a vital step toward understanding psilocybin's therapeutic potential in Opioid Use Disorder. Our collaboration with Dr. Bogenschutz aims to create a treatment pathway that is accessible, effective, and safe, opening new avenues for psychedelic-assisted therapy as an FDA-approved tool in the fight against addiction."

Dr. Bogenschutz highlighted the broader implications of the trial, noting, "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 offer a new option for OUD patients who are receiving treatment but continue to struggle with illicit opioid use."

B.More Inc., founded in 2017 by Carey and Claudia Turnbull, is dedicated to developing better treatment options for those struggling with alcohol use disorder and other substance use disorders. In collaboration with researchers at the NYU Grossman School of Medicine, the organization is advancing clinical research to help individuals and their loved ones achieve a better future.

This trial also complements an ongoing NIH-funded study on alcohol use disorder at NYU's Silver Hill rehab center, further enhancing NYU's expertise in treating substance abuse with psilocybin.