Researchers have shown that psilocybin is safe in doses of either 10mg or 25 mg, with no adverse effects to short-term or long-term health. The same study also affirmed the safety of scaling the administration of psilocybin to a large number of patients simultaneously, offering hope for using the drug to treat a wide range of medical conditions.
BACKGROUND: PSILOCYBIN TREATMENTS SHOW MEDICAL POTENTIAL
Although marred by a cultural stigma attached to the recreational use of “magic mushrooms,” the potential medical benefits of the active drug in psilocybin for conditions like Treatment Resistant Depression (TRD) or Post Traumatic Stress Disorder (PTSD) are fueling numerous research efforts into the potent fungus.
The Debrief has previously reported on such research into the potential benefits of psilocybin on these and other medical conditions, including possible benefits for treating alcohol use disorder. However, like any drug targeting human medical conditions, the issue of safety is a primary concern.
With this latest study, researchers set out to determine whether psilocybin is safe when administered at therapeutically viable doses, both on short-term and long-term health, while also measuring the viability of treating large groups of patients simultaneously.
ANALYSIS: STUDY SHOWS PSILOCYBIN IS SAFE AND SCALABLE
According to the press release, this involved 89 healthy study participants with no psilocybin use within the previous year. Of that group, 60 were randomly selected to receive psilocybin in either 10mg or 25mg doses, while the other 29 were given a placebo. The participants were then placed in a controlled environment with one-to-one support from psychotherapists and were monitored for six to eight hours following the psilocybin administration.
Over the ensuing 12 weeks, the study participants were assessed for a number of possible changes, including “sustained attention, memory, and planning, as well as their ability to process emotions.”
According to the final study, which was published in the Journal of Psychopharmacology, no participants left the study due to adverse reactions, and none reported any ill effects to their mental or physical health afterward.
This successful study “explored the safety and feasibility of simultaneous psilocybin administration, with 1:1 support, in healthy participants,” said Professor Guy Goodwin, Chief Medical Officer at COMPASS pathways and a study co-author.
“This rigorous study is an important first demonstration that the simultaneous administration of psilocybin can be explored further,” added the study’s lead author Dr. James Rucker from the National Institute for Health Research. “If we think about how psilocybin therapy (if approved) may be delivered in the future, it’s important to demonstrate the feasibility and the safety of giving it to more than one person at the same time, so we can think about how we scale up the treatment.”
OUTLOOK: PSILOCYBIN TRIALS SHOWING PROMISE
Although more research is needed to clear the way for prescription use of psilocybin, according to the press release, “the investigators have since completed Phase II of the study, which has explored the efficacy and safety of psilocybin in people living with TRD and PTSD,” and they are currently analyzing the data.
“This therapy has promise for people living with serious mental health problems, like treatment-resistant depression (TRD) and PTSD,” concluded Rucker. “They can be extremely disabling, distressing and disruptive, but current treatment options for these conditions are ineffective or partially effective for many people.”
Follow and connect with author Christopher Plain on Twitter: @plain_fiction