As the opioid crisis continues to grow around the world, conventional approaches to treating substance use disorders (SUDs) are falling short.
However, a possible solution has emerged from an unexpected source - psychedelics. While psychedelics were once associated with counterculture movements, promising clinical research into psychoactive compounds like psilocybin is shedding light on their therapeutic potential for the treatment of SUDs.
The statistics surrounding substance use disorders in North America are staggering. Among Americans aged 12 or older in 2021, 8.6% (24 million people) had at least one drug use disorder in the past year according to the 2021 National Survey on Drug Use and Health. The same survey found that 9.2 million Americans reported opioid misuse and 5.6 million reported an opioid use disorder. In Canada, opioid-related deaths continue to rise, with over 17,000 deaths occurring between January 2016 and June 2020, according to the Public Health Agency of Canada. These numbers underscore the urgent need for innovative interventions to address the opioid crisis and alleviate the burden of addiction on individuals, families, and communities.
Enter psilocybin, a psychoactive compound found in magic mushrooms. In recent years, psilocybin has gained recognition for its therapeutic potential in treating a range of mental health conditions, including SUDs. Studies have shown that psilocybin-assisted psychotherapy can lead to profound, transformative experiences characterized by increased feelings of interconnectedness, introspection, and emotional release. These experiences may help individuals struggling with addiction break free from the cycle of substance abuse by addressing underlying psychological and existential distress.
A number of studies reinforce the potential for psychedelics to treat SUDs. For example:
- A study by Savage et al. in 1973 examined the rehabilitative efficacy of LSD psychotherapy among chronic heroin users and found that it resulted in 25% greater abstinence from opioids versus 5% with the control.
- A 2016 study at Johns Hopkins University found that two to three doses of psilocybin in combination with cognitive behavioral therapy for smoking cessation resulted in substantially higher 6-month smoking abstinence rates (67%) than are typically observed with other medications or CBT alone.
- A 2022 clinical trial at New York University found that psilocybin administered in combination with psychotherapy produced robust decreases (83%) in the percentage of heavy drinking among people with alcohol use disorder compared with those produced by active placebo and psychotherapy.
- In 2002, Krupitsky et al. found that high-dose ketamine therapy demonstrated significantly higher abstinence in patients with heroin addiction versus the control.
In the context of OUD, psilocybin therapy offers a multifaceted approach to treatment. Beyond merely managing withdrawal symptoms or cravings, psilocybin-assisted psychotherapy aims to tackle the root causes of addiction, such as trauma, depression, and existential despair. By facilitating profound insights and spiritual experiences, psilocybin therapy has the potential to catalyze deep-seated changes in perspective and behavior, leading to sustained recovery and improved quality of life.
While the research into psilocybin's therapeutic potential is still in its early stages, preliminary findings are encouraging. Studies have demonstrated significant reductions in substance use, decreased cravings, and improvements in mood and overall well-being following psilocybin therapy sessions. These results suggest that psilocybin could offer a novel and effective treatment option for individuals grappling with OUD and other SUDs.
At Filament Health, we firmly believe in psilocybin’s potential to help treat substance use disorders. Our internal drug development efforts are squarely focused on SUDs such as opioid use disorder and stimulant use disorder because there are very few viable treatments for these conditions and an urgent need to find a solution.
We have attained FDA approval for a Phase II clinical trial at the University of California San Francisco studying PEX010, Filament’s botanical psilocybin drug candidate, for methamphetamine use disorder and we are the sponsor of a Phase II clinical trial at the University of British Columbia which is examining the effects of PEX010 for OUD. In January of this year, we announced that the FDA accepted our Investigational New Drug (IND) application for PEX010 for the treatment of SUDs. The active IND allows the initiation of US research of PEX010 for the potential treatment of substance use disorders including OUD.
Filament also has a robust network of partners who license PEX010 for use in their own clinical trials (27 and counting). Many of these clinical trials are investigating SUDs including at Johns Hopkins for cannabis use disorder, at the University of Calgary, Brugmann University Hospital, and Copenhagen University Hospital for alcohol use disorder, and at the University of British Columbia Okanagan for opioid tapering.
In summary, psilocybin-assisted psychotherapy shows significant promise as an innovative and effective approach to treating SUDs. As research evolves, we will continue to expand our understanding of how psilocybin therapy can alleviate the symptoms of SUDs, offering hope for individuals grappling with addiction and paving the way for transformative advancements in addiction treatment.
