Changing the treatment paradigm

Research

OUR RESEARCH
A new treatment paradigm
Today, there exists no effective and lasting treatment for those struggling with alcoholism. With a 70% relapse rate among those receiving available treatments, a pressing need exists for a safe and effective alternative.
We believe psilocybin-assisted psychotherapy is the answer to alcoholism and other substance use disorders, with current studies demonstrating its efficacy and long-lasting positive effects.
WHY PSILOCYBIN?
A promising treatment for substance use disorders
Scientific and clinical research has produced promising results in the treatment of alcoholism with psilocybin in combination with psychotherapy.
  • Generally well-tolerated
  • Produces rapid and sustained clinical effects
  • Increases alcohol abstinence and reduction in alcohol consumption and heavy drinking days

Academic study

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An initial pilot study on AUD conducted by Dr. Michael Bogenschutz at the University of New Mexico produced statistically significant results with promising effect sizes.

Phase 2a proof of concept trial

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Published in JAMA Psychiatry in August 2022, a Phase 2a clinical trial led by B. More principal investigator, Dr. Michael Bogenschutz, reported an 83% average reduction in heavy drinking among those receiving psilocybin combined with psychotherapy.   Additionally, the study showed that 8 months after their first dose, almost half (48 percent) of those who received psilocybin stopped drinking altogether compared with 24 percent of the placebo group.

Proposed Phase 2b trial

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The Phase 2b trial will assess the efficacy and safety of synthetic psilocybin (SYNP-102) in treating moderate to severe AUD. The trial plans to enroll a total of 210 participants who will receive psychotherapy and one administration of 30mg of SYNP-102 or an active placebo.

Having invested millions of dollars and undertaken over 10 years of research,  B.More is now positioned to commence a pivotal trial designed to secure FDA approval of prescription medicine status for the use of psilocybin to treat alcoholism. Obtaining adequate funding for this trial remains a critical priority for helping the millions of Americans who struggle with alcohol dependence. We welcome your support in making better treatment options a reality.

COLLABORATORS
Dr. Michael Bogenschutz
B.More works with collaborators like Dr. Michael Bogenschutz and NYU Langone Health specifically providing clinical supplies and support for his work with AUD and OUD.
Dr. Bogenschutz investigates the therapeutic potential of serotonergic psychedelic drugs such as psilocybin and focuses on the neurobiological and clinical effects of psilocybin in patients with addiction, including alcohol use disorder (AUD) and opioid use disorder (OUD).
In patients with alcohol use disorder (AUD), Dr. Bogenschutz is using fMRI and objective tasks as well as self-report questionnaires to elucidate the effects of psilocybin on core domains of the AUD phenotype including incentive salience, negative affect, and executive functioning. He will evaluate the extent to which these effects account for clinical outcomes.
Dr. Bogenschutz is also conducting a multi-site trial of the effects of psilocybin in patients with OUD who are receiving methadone but continue to use illicit opioids (e.g., fentanyl and heroin). Both of these studies recruit patients who are already receiving treatment in community-based treatment programs, which enhances the generalizability of the clinical results. B.More is providing the psilocybin clinical supplies for both of these important studies.
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