Dr. Michael Bogenschutz Receives NIAAA Grant for Psilocybin Alcohol Use Disorder Trial

B.More Inc., a clinical-stage biopharmaceutical non-profit organization based in Greenwich, Connecticut, has announced that its collaborator, Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, has secured a $3.8 million grant from the National Institute of Alcohol Abuse and Alcoholism (NIAAA). This grant is intended to support a comprehensive study on the brain mechanisms underlying psilocybin-assisted treatment for alcohol use disorder (AUD), with the aim of enhancing the understanding of its safety, efficacy, and practical application in real-world settings.

The clinical trial will be conducted at Silver Hill Hospital (SHH), which will recruit participants and provide residential treatment. B.More Inc. will contribute by supplying the cGMP psilocybin required for the trial and funding an independent monitor to ensure high-quality data collection suitable for a future New Drug Application (NDA). This trial's location in a well-established substance abuse treatment center is expected to offer valuable insights for the eventual commercialization of psilocybin and support evidence for cost-effective insurance reimbursement. The NIAAA's involvement reflects a rising interest in the potential of psychedelic medicines.

Carey Turnbull, Co-founder and CEO of B.More Inc., emphasized the significance of this grant, highlighting Dr. Bogenschutz's innovative work in developing new treatment modalities for AUD. He conveyed optimism that this trial could lead to more effective treatments for AUD and other substance use disorders, thereby providing renewed hope for many individuals struggling with addiction. B.More Inc. is enthusiastic about partnering with Dr. Bogenschutz and his team to support this pioneering research.

The study is designed as a double-blind, randomized, placebo-controlled Phase 2 trial. It aims to explore the therapeutic neural mechanisms of psilocybin in AUD patients using advanced functional magnetic resonance imaging (fMRI). The trial will compare treatment differences between high-dose psilocybin (30 mg) and an inactive placebo, focusing on changes in fMRI metrics, drinking outcomes, and self-reported measures of negative emotions, cravings, and executive function. The research also aims to identify neural predictors of successful treatment outcomes, particularly in response to high-dose psilocybin.

Collaboration with SHH will see 120 participants randomized from SHH’s 28-day residential treatment program. Primary outcomes will assess changes in neural activation, connectivity, and self-reported alcohol use and related psychological measures. Silver Hill Hospital, located in New Canaan, Connecticut, is a nationally recognized, not-for-profit institution specializing in the treatment of psychiatric and addictive disorders, serving over 3,500 patients each year.

Andrew J. Gerber, MD, PhD, President and Medical Director of Silver Hill, expressed satisfaction with the hospital's involvement in this critical trial to advance care for individuals with alcohol use disorder. Dr. Michael Bogenschutz also shared his excitement about the study, citing the NIAAA's generous support as validation of psilocybin’s promise as a transformative therapy for substance abuse disorders. He emphasized the commitment to deepening the understanding of how psilocybin affects neural mechanisms and contributes to recovery.

Founded in 2017 by Carey and Claudia Turnbull, B.More Inc. is dedicated to developing better treatment options for those struggling with alcohol use disorder and other substance use disorders. Named in honor of Claudia Turnbull's brother, Brett Moore, who died of a drug overdose 50 years ago, B.More focuses on the development and commercialization of psychedelic medicines that have the potential to significantly improve the lives of individuals for whom current treatments have been ineffective. In collaboration with researchers at the NYU Grossman School of Medicine, B.More is advancing clinical research to help these individuals and their loved ones achieve a better future.