Psilocybin, the psychoactive compound in magic mushrooms, is proving a prodigious treatment for anxiety, depression, addiction, and one study even found it may lead to neurogenesis, or the regrowth of brain cells. So when will doctors finally be able to write prescriptions for psilocybin? In this opinion piece Dr. David E. Nichols, psychedelic research expert and co-founder of The Heffter Research Institute, explains what steps it will take to get medicinal psilocybin legalized.

Many people have now seen media stories about the renewed research interest in psychedelics as medicines, often called a “renaissance” in psychedelic research, over perhaps the past five years or so. Although many psychedelic substances have been used safely as medicines in indigenous cultures for millennia, we are now seeing renewed interest in these substances in Western cultures. As a co-founder of the Heffter Research Institute I have watched with an increasing sense of both amazement and gratitude — that we have been able to accomplish so much in such a relatively short time. We are on the path to make psilocybin into a prescription medicine! The Heffter Institute has been a key driver of this “renaissance,” utilizing most of the donations we receive directly to support clinical research.

Heffter initially provided major funding for a small study of psilocybin treatment for obsessive-compulsive disorder (OCD) patients, at the University of Arizona. That study provided mixed but encouraging results that have yet to be pursued due to funding limitations.

Our first truly successful study was treatment of 12 terminal cancer patients who suffered from anxiety and depression. They were treated with a program of therapy that included psilocybin, the active component in so-called magic mushrooms. Participants showed a significant reduction in anxiety at one and three months after treatment, with no significant adverse events. That study, led by Dr. Charles Grob at the UCLA Harbor Medical Center, was published in 2011 in Archives of General Psychiatry, widely recognized as perhaps the top psychiatry journal in the world.

Subsequently, two additional studies were begun using psilocybin to treat anxiety and depression in cancer patients, one at Johns Hopkins University led by Dr. Roland Griffiths, and the other at New York University (NYU) directed by Dr. Stephen Ross. The patients in both studies have almost completed their treatments, then the studies will start the follow-up and data analysis stage. Preliminary analysis points again to significantly decreased anxiety and depression.

In addition, the Heffter Institute recently sponsored a study of psilocybin-assisted therapy in a pilot study of 10 volunteers with alcohol dependence. The principal investigator for this study was Dr. Michael Bogenschutz, at the University of New Mexico (UNM). Drinking decreased significantly beginning in the second month of treatment, after psilocybin was administered, and improvement remained significant for an additional six months of follow-up. There were strong correlations between the intensity of the experience in the first psilocybin session and clinical improvement following the session. Based on the positive findings from this pilot study, we are now implementing a larger randomized trial at UNM and NYU.

We also recently supported a pilot study by Dr. Matthew Johnson at Johns Hopkins, administering psilocybin within a 15-week smoking cessation treatment. Participants were 15 healthy smokers with a mean of six previous lifetime quit attempts who were smoking an average of 19 cigarettes per day for 31 years. Measures of smoking behavior showed that 12 of the 15 participants (80%) were no longer smoking at six-month follow-up. This smoking cessation rate substantially exceeds rates commonly reported for other types of therapies (typically less than 35%). These findings suggest that psilocybin may be a useful and potentially efficacious adjunct to current smoking cessation treatment approaches, and warrant a follow-up clinical trial. Results also illustrate a framework for research on the efficacy and mechanisms of psychedelic-facilitated addiction treatment.

When people hear that we are sponsoring medical research with psilocybin, they often ask, “How long before doctors will be able to prescribe it?” The process to get there is both expensive and time-consuming. To get a drug to market, that is, to make it into a medicine, there are three clinical phases that must be completed. Phase 1 involves giving a new drug to humans to determine whether it can be tolerated, if it is safe, and what doses are acceptable. For psilocybin, there are extensive data with respect to doses and safety of psilocybin, particularly as it has been used in the form of psychedelic mushrooms since prehistoric times. Further, none of the participants in our treatment studies has required medical or psychiatric intervention.