hrough the screening and preparation procedure in our medical setting. About 30 percent of our people reported some fear or discomfort arising sometime during the experience. If individuals are anxious, then we might say a few words, or hold their hand. It is really just grounding them in consensual reality, reminding them that they have taken psilocybin, that everything is going to be alright. Very often these short-lived experiences of psychological challenge can be cathartic and serve as doorways into personal meaning and transcendence—but not always.
Where do you go from here?
The Heffter Research Institute, which funded our study, has just opened a dialogue with the FDA (Food and Drug Administration) about initiating a phase 3 investigation. A phase 3 clinical trial is the gold standard for determining whether something is clinically efficacious and meets the standards that are necessary for it to be released as a pharmaceutical. Approval would be under very narrow and restrictive conditions initially. The drug might be controlled by a central pharmacy, which sends it to clinics that are authorized to administer psilocybin in this therapeutic context. So this is not writing a prescription and taking it home. The analogy would be more like an anesthetic being dispensed and managed by an anesthesiologist.
You are also currently conducting research on psilocybin and smoking.
We are using psilocybin in conjunction with cognitive behavioral therapy with cigarette smokers to see if these deeply meaningful experiences that can happen with psilocybin can be linked with the intention and commitment to quit smoking, among people who have failed repeatedly to do so. Earlier we ran an uncontrolled pilot study on that in 50 volunteers, in which we had 80 percent abstinence rates at six months. Now we are doing a controlled clinical trial in that population.
How do you account for your remarkable initial results?
People who have taken psilocybin appear to have more confidence in their ability to change their own behavior and to manage their addictions. Prior to this experience, quite often the individual feels that they have no freedom relative to their addiction, that they are hooked and they don’t have the capacity to change. But after an experience of this sort—which is like backing up and seeing the larger picture—they begin to ask themselves ‘Why would I think that I couldn’t stop cigarette smoking? Why would I think that this craving is so compelling that I have to give in to it?’ When the psilocybin is coupled with cognitive behavioral therapy, which is giving smokers tools and a framework to work on this, it appears to be very helpful.
You are also working with meditation practitioners. Are they having similar experiences?
We have done an unpublished study with beginning meditators. We found that psilocybin potentiates their engagement with their spiritual practice, and it appears to boost dispositional characteristics like gratitude, compassion, altruism, sensitivity to others and forgiveness. We were interested in whether the psilocybin used in conjunction with meditation could create sustained changes in people that were of social value. And that appears to be the case.
So it is actually changing personality?
Yes. That is really interesting because personality is considered to be a fixed characteristic; it is generally thought to be locked down in an individual by their early twenties. And yet here we are seeing significant increases in their “openness” and other pro-social dimensions of personality, which are also correlated with creativity, so this is truly surprising.
Do we know what is actually happening in the brain?
We are doing neuro-imaging studies. Dr. Robin Carhart-Harris’s group at Imperial College in London is also doing neuro-imaging studies. So it is an area of very active investigation. The effects are perhaps explained, at least initially, by changes in something [in the brain] called “the default mode network,” which is involved in self-referential processing [and in sustaining our sense of ego]. It tu