BHE Psychedelics Podcast, Episode 004 – Paul Thielking, MD, Novamind Chief Scientific Officer

Paul Thielking, MD, chief scientific officer for Novamind, joins the BHE Psychedelics Podcast to discuss the clinical trials currently being conducted by Novamind and the potential applications for the psychedelics the company is researching. Dr Thielking also shares how psychedelics are garnering interest from physicians in a variety of specialties, where the field is headed in the coming years, and issues that will need to be navigated, from getting insurers on board to developing the infrastructure needed in clinics to facilitate psychedelic treatments.

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TRANSCRIPT

Tom Valentino: Hello, and welcome to the BHE Psychedelics Podcast. Today, we are joined by Dr Paul Thielking, chief scientific officer for Novamind. Dr Thielking, welcome to the show.

Dr Paul Thielking: Hi, Tom. Thanks for the invitation. Good to join you today.

Valentino: Give us a little elevator pitch on Novamind, and tell us a little bit about the work that you’re currently doing.

Dr Thielking: Novamind is a mental health organization. We have both a network of behavioral health clinics, most of them located here in Salt Lake City. We also have a clinical research site and are planning to expand to have a network of clinical research sites with a specific focus on this emerging field of psychedelic medicines.

We have clinics and research sites that function as a united whole. We’ve been running ketamine clinics in our organization for a few years now. That’s serving as a basis for leading us into these other emerging psychedelic medicines.

Valentino: Novamind is contracted for 8 clinical trials by some top drug developers. I know there are some things you can talk about, and some things you can’t just yet until those go public. What can you tell us about those trials? What kinds of psychedelics are you researching? What kind of potential applications do they have?

Dr Thielking: To start with, a lot of the clinical trials that are currently underway with us are for standard mental health treatments. For example, we have a couple of trials going on for schizophrenia, PTSD, and depression that are not psychedelic.

We have the infrastructure to run these clinical trials. We’ve created a space that’s specifically designed for this next wave of psychedelic studies. There are currently quite a few studies going on with psilocybin, for example, that have moved into phase II, which are multisite larger‑scale studies, and soon to be phase III.

With MDMA, there’s currently a second phase III study going on that’s a multisite study. To run these kinds of psychedelic studies, you need a specifically designed space that’s a little different than what we would normally use for clinical research trials. Right now, most of the trials we have going on are for your standard psychotropic medicines.

Valentino: Can you take us into the weeds a little bit and walk us through the process for 1 of these clinical trials, in terms of how you’re recruiting patients, how you’re conducting trials, if there’s differences in terms of the process based on which compounds are being studied? What can you tell us on that front?

Dr Thielking: What I can say is 1 of the advantages to having both a research site and a network of clinics is we naturally have a large patient base to draw from. A lot of our referrals for research studies come directly from our clinics.

We also do other kinds of advertising campaigns. Then, the drug sponsors often have their own campaigns that they’ll run to generate that flow of referrals into the research studies. To go into a little more detail with psychedelic study, first of all, there’s a lot of interest in psychedelic medicines now.

In general, they tend to be relatively easy to recruit for because there are a lot of people seeking out these studies, looking to get into them. We anticipate that as more of them come down the pipeline, that we’ll still draw them from our network of clinical sites, but there’ll be relatively easy to recruit for.

If you look on clinicaltrials.gov, which is where any new drug study that’s going on is logged in and registered, you’ll find that there are, I believe over 50 current studies going on for psilocybin alone. They range from depression to obsessive‑compulsive disorder, to substance‑use disorders, to migraine, headaches, and phantom limb pain.

There’s quite a wide range of conditions for which psychedelic studies are being done currently, and it’s only going to expand in the coming months and years.

Valentino: It’s such a wide range of that potential and possibilities that we’re seeing here. It seems like so much of this has been emerging in recent years as well. Do you get a lot of interest or inquiries from other provider organizations, too? Might not necessarily be directly involved with anything psychedelics‑related now, but have had their curiosity peaked.

Dr Thielking: The field is emerging and it is becoming more mainstream. For example, I came from an academic background at the University of Utah. A couple of years ago when I started talking about wanting to do a psilocybin study there, it was new. People didn’t know quite what to make of it, and there was healthy skepticism.

Now, fast‑forward a couple of years, where we’re running a pilot study up there and we’ve got others that we’re launching here at Novamind, I’m getting actively sought out by physicians from a range of specialties inquiring about these studies in addition to here locally, a lot of folks that had colleagues in the community that worked for other health groups.

It’s become quite known. There’s a lot of interest, not just from patients, but also from providers. We’re getting inquiries from a variety of groups on a regular basis.

Valentino: What do you see is the future here? We’ve made so much progress in recent years. Where are things headed in the next 3 to 5 years, so to speak? What is the conversation between you and I going to look like 5 years from now?

Dr Thielking: There are a lot of unknowns when you ask that question. We are at a pivotal point here, in the sense that a lot of these early‑phase studies that are smaller, not as rigorous perhaps, have been very promising.

As some of the cutting‑edge groups are getting into the late phase II and phase III of clinical trials, we’re going to learn, “Are these medicines effective? When you compare them to a control group or a placebo and started ministering them to large numbers of people, are they effective? Are they safe?”

In the next 2 years, we’re going to get the answer to that with MDMA, for post‑traumatic stress disorder. Then in the next 3 to 4 years, we’re probably going to get that answer for psilocybin, for depression.

If those large‑scale phase III trials are positive, 1 or both of those medicines is likely to be FDA‑approved and have an indication.

Instead of us talking about it as a research medicine, we’re going to be talking about it in the context of “How do we make this new treatment that’s illegal now available? How do we take it from small‑scale studies to large‑scale population, and make it accessible, and have the infrastructure to provide the intervention?”

It is different than what we’ve been providing in mental health care up‑to‑date, which is primarily giving people medication. Sending them home, they take it on their own on a daily basis.

It’s a much different model of care we’re talking about with psychedelic therapies. It’s going to have a whole host of challenges as we think about scalability and accessibility.

Valentino: That was the last thing I was going to ask you. What are the biggest roadblocks and potential challenges to overcome in this?

Dr Thielking: One of the biggest challenges and potential roadblocks is this is a more...It’s not just medication that we’re giving people when we’re using psychedelics. We’re combining it with therapeutic support.

A standard treatment intervention with psychedelic involves 2 therapists for 1 person over, for a dosing session, an 8‑hour a day. It’s very resource‑intensive. Very effective potentially, but requires a lot of therapeutic resources.

There’s a bottleneck. How do you train the number of therapists that are going to be needed? How do you find them? How do you reduce costs? If you’re talking about 2 therapists for 1 person for a full day, that’s quite costly. The bottleneck is with trained therapists.

Then the other big challenge I see is how do we make it affordable, accessible? How do we get insurance payers, onboard? How do we create the spaces, the infrastructure in clinics where you can set 2 therapists aside for a day, and have a nice living room‑type environment for a person to be there for a whole day?

Most mental health clinics don’t have those kinds of spaces. That’s what we’re focused on here at Novamind is creating some of the infrastructure to run the research studies now, and eventually, to hopefully in a couple of years, be talking about how do we provide these FDA‑approved medicines to folks within this mental health clinic infrastructure?

Valentino: Good stuff. Dr Paul Thielking, thank you so much for taking the time. We really appreciate it.

Dr Thielking: Yeah, thank you, Tom. Appreciate the time and the interest in this topic. Thank you.

Valentino: As a reminder, you can stream past episodes of The BHE Psychedelics Podcast, as well as our flagship, BHE Podcast on our website, behavioral.net.

Our thanks once again to Dr Paul Thielking, Chief Scientific Officer from Novamind. I’m BHE Digital Managing Editor, Tom Valentino, and this has been the BHE Psychedelics Podcast.