Arizona researchers will study ibogaine as PTSD, brain injury treatment. What it will look like

Barrow Neurological Institute expects to start enrolling patients next year in a research study testing whether the psychedelic ibogaine can safely treat people with certain neurological disorders.

The study is the result of a $5 million grant from the state, and will test potential treatments for patients with conditions like traumatic brain injury and post-traumatic stress disorder.

The Show spoke with Dr. Susan Criswell, chief medical officer for clinical research at Barrow Neurological Institute, starting with what this study will look like.

Full conversation

SUSAN CRISWELL: Kind of the overall question that we’re going to ask is whether ibogaine can be administered safely and whether it can help people with persistent symptoms from traumatic brain injury, or TBI.

So to do that, we’re proposing a what’s called a Phase I/II double-blind, placebo-controlled trial. This is funded by the state of Arizona, which we are very appreciative of. And we are going to enroll 40 adults with chronic traumatic brain injury symptoms, and this will be conducted jointly with researchers at the Barrow and at Arizona State University. And half of the participants will receive a single dose of ibogaine and half a placebo. And then we will follow those people for six months really to determine whether there are improvements in their symptoms that persist.

MARK BRODIE: Do you have a hypothesis of what you think might happen?

SUSAN CRISWELL: Well, we do have a hypothesis, but of course we have to test that hypothesis. And like I said, the question is really, does ibogaine improve symptoms in people with traumatic brain injuries, especially persistent symptoms? And those would include things like cognitive and emotional and physical difficulties. We know that people with TBI often also suffer from PTSD and depression and anxiety-related symptoms, and just in general struggle with things in their daily life.

And we will be measuring all of those things at baseline, they will receive the treatment, and then afterwards we would follow up on those symptoms to see if we see changes. I’d like to say this is also a very early-phase trial, so we’re also very focused on safety in this trial. And that’s actually our number one thing that we’re going to look at is, is ibogaine safe to administer to individuals with TBI?

And so this trial is going to be conducted in an intensive care unit in a very well-monitored inpatient setting, and we will be doing cardiac monitoring, we’ll be doing regular vital signs, we’re going to administer magnesium, and we’re really focused on making sure the safety aspect is well assessed.

MARK BRODIE: Do you have a sense, just sort of based on research that’s been done already or just your own reading of it, of what the potential of ibogaine is? Could this really be a big help for folks with traumatic brain injuries or PTSD or things like that?

SUSAN CRISWELL: Well, I think you referenced some of the early anecdotal study information that’s been published is really interesting and exciting. And I think the underlying premise is that could ibogaine sort of rewire or help to reorganize and adapt the human brain? This concept is known as neuroplasticity, so one of the questions is, could ibogaine be a neuroplastogen? And you could imagine how that might be helpful in someone with a traumatic brain injury.

And we are kind of going to dig into that mechanism aspect a little bit. So we’re doing MRIs at baseline, and then after ibogaine administration, we’re also going to do EEG, looking at sort of that functional connections in the brain and see if they change with ibogaine administration. So we are going to try and dig into that mechanism part of it a little bit to see if we can understand some of that biology that might be occurring when ibogaine is administered.

MARK BRODIE: Are there certain neural connections, like specific ones, that you’re looking at to see if ibogaine affects/improves?

SUSAN CRISWELL: Well, when we do MRI and EEG in this case, it’s really looking at whole-brain connections, so it’s not necessarily focused on one, but some of the early studies do indicate there are multiple neurotransmitters and connections that are changed with administration.

MARK BRODIE: What have you learned from some of the other studies that have been going on or have been done about this that will maybe inform what you’re doing here and maybe what you’re looking for here?

Barrow Neurological Institute

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SUSAN CRISWELL: Well, I think some of the early studies, we’re building on some of the testing that they did and sort of building and expanding. Remember, some of these early studies are not blinded, so the participant, the investigators, they all know what’s being administered. And so kind of taking it to that next step is when you start to do double-blinded, rigorous scientific studies and replicate some of those findings that we saw in the early studies.

MARK BRODIE: Does the fact that this is relatively new and sort of a trendy thing to talk about, there’s a lot of buzz around it, does that impact what you’re doing or how you’re doing it or the fact that you are doing it in any way?

SUSAN CRISWELL: Well, I think it does give us the potential to do the study. Interest helps generate interest in funding studies and providing the resources we need to conduct these types of studies, so we’re very appreciative of that. But as far as the scientific rigor, I think we follow what we traditionally use for a Phase I/Phase II trial in any medication that we’re testing to see if it might improve neurological outcomes.

MARK BRODIE: So I know that you’re looking to enroll people starting next year. What does the timeline look like after that? Once you start getting folks in this study, how long do you think it’ll take, when might you have a sense of what the results might be?

SUSAN CRISWELL: Sure. So that’s correct, we are for the next year doing regulatory work, we’re getting contracting, and as you said, this is a drug that’s not been administered in the United States before, so this is a lengthy process for us to work through. But we are anticipating first participant enrolled hopefully about a year from now at this time. And then we’ll be enrolling over the next probably two to three years. It’s a total of five years for the study, and so the last year will really be focused on writing up results, publishing our findings, and that sort of thing.

But remember, we’re following people for six months, so even when we enroll someone in the second year, we still have to do the follow-up on all the participants and do our subsequent testing, so that does take a little bit of time.

MARK BRODIE: Is there a reason why you decided to look at ibogaine as opposed to any other psychedelics that people are talking about that may also hold potential for treating some of these ailments?

SUSAN CRISWELL: Well, in this case, this was the ask from the state of Arizona. They did want a project focused on ibogaine specifically, and there is, of course, a lot of public information about that that seems like it may be a promising medication. So I think those two combined kind of brought this grant application and this proposal into fruition.

LAUREN GILGER: Dr. Susan Criswell is chief medical officer for clinical research at Barrow Neurological Institute.