Expert: Studies Assessing Psilocybin Show Patients Experience Improved Diet, Increased Exercise, Overall Positive Sense of Wellbeing

Pharmacy Times interviewed Clive Ward Able, MD, BPharm, president of Clintell, consultant to NeonMind Inc, and a trained pharmacist and physician, on his research into the use of psilocybin to treat obesity and optimize human health.

Ward Able noted that although there haven't been any clinical studies assessing psilocybin as a treatment for obesity, there have been positive signals from other studies on this subject that were conducted to assess psilocybin in the treatment of depression, post-traumatic stress disorder, alcoholism, or tobacco smoking cessation.

During these studies, data relating to weight were not a primary endpoint or even a secondary endpoint, but when investigators queried patients following treatment, up to 60% spontaneously mentioned that they had experienced an improvement in diet as well as an increase in exercise and an overall sense of wellbeing and positivity. These feelings also spread across not only how they felt about themselves, but also how they felt about their relationships with others and their body image.

Because of these results from prior clinical studies, Ward Able’s research team looked to assess the promise for specifically targeting obesity and the potential triggers that lead to other negative behaviors within the obesity population.

“We should be having the first patient in the first quarter of next year,” Ward Able said. “That proof of concept study can teach us a ton about what the right patient is, how to do that, etc. Ultimately, we're looking at having it commercially available for patients in clinics probably within a 5-year time frame.”

Ward Able also noted that research into the potential medical use of psychedelics such as psilocybin is separate to their recreational use. Considering this, issues around the legalization of psychedelic medicine in certain states or countries are not relevant to medical research being conducted.

“The way we expect this to be regulated would be very much similar to any other pharmacological agent. It's going to have to go through regulatory approvals, it's going to have to have studies that assess a specific indication in the treatment of patients, and it’s going to be in a very controlled clinical setting. This will not be something that you do at home,” Ward Able said. “It's going to be very important for all researchers within the space right now to make sure that this is not connected to recreational use.”

In this way, psilocybin would be prescribed by a physician and administered by another certified health care professional. In a clinic, this health care professional would provide a psilocybin capsule to the patient as a part of a drug-enhanced psychotherapy protocol.

“It's very similar to what's being done now with ketamine, which is approved for treatment-resistant depression,” Ward Able said.

Historically, psychedelic medicine research had been shut down in the late 1960s. Because of this, in the 1980s and early 1990s, there was very little research being done due to the presence of the legal obstacles that existed at the time.

“I think moving forward, both the FDA and Health Canada are much more open to the possibility now of approving or looking at assessing a psychedelic in these treatments following clinical, well-researched, and supported studies,” Ward Able said. “Like any other pharmaceutical, this is the way it will be regulated. There are a few extra little hurdles to get over now, but then, to me, they're not going to be onerous to get over.”