Tuesday, September 26, 2023

Association Studies PTSD Treatment for Veterans

An Interview With MAPS’ Berra Yazar-Klosinski


Cannabis has been touted as a miracle treatment for veterans suffering from PTSD, but the topic needs much more study before public policies can embrace it. The Multidisciplinary Association for Psychedelic Studies (MAPS), which is based in San Jose, Calif., recently received funding to support a massive study of the efficacy of cannabis as a PTSD treatment. We spoke with MAPS Deputy Director and Head of Research Development and Regulatory Affairs Berra Yazar-Klosinski about the study and what it could mean for veterans.

The Paper.: Can you tell me about the recent grant that MAPS received and what it’s for?

Yazar-Klosinski: MAPS was recently awarded almost $13 million in grant money from the state of Michigan for conducting phase 2B clinical trials examining the efficacy and safety of botanical cannabis for the treatment of PTSD, and the route of administration we’ll be studying is inhaling.

I’d like to know more about the methodology. How much are you actually allowed to do? I know your hands are tied when it comes to certain avenues of research.

Well, the study is built upon a prior pilot study that we conducted that was funded by the Colorado Department of Public Health and Environment. We tested smoked cannabis in that one. We compared placebo cannabis to high THC to high CBD to balanced THC and CBD.

The pilot study was originally conducted with a constrained supply. We were required to use cannabis obtained from the University of Mississippi. Because at the time there was only one sole source that was allowed for conducting federally regulated clinical trials of cannabis.

With this new study, we’ve learned a lot from the design of the first study and used it to calculate a larger sample size that would enable us to potentially detect a significant difference—if one exists—between high THC and placebo cannabis.

Our power calculations suggest that we might need to study 320 veterans in order to detect the difference between the groups, but it’s also possible that we might need less veterans if the cannabis quality is better.

We’re currently on clinical hold for the trial itself until we can resolve some questions from FDA, but we’re actively working on the response. And part of that will be to specify exactly which strain of cannabis we’re going to use for the study, and we have to wait for the growth cycles to resolve until we can answer that. In the meantime, we’re doing the systematic literature review to analyze the safety of inhaling up to 2 grams of cannabis per day. And there’s a lot of international work that's been allowed to take place—in Australia, Israel and Canada—and we’ll be leveraging those publications to show that veterans are benefiting in these international countries from being able to use cannabis to manage their symptoms. And the safety of it is adequate for them to be able to justify medical insurance coverage of cannabis through the veterans administrations in these countries. We would like our veterans to have the same options. And in order to do that, we have to conduct a federally regulated, appropriately designed clinical trial to study what the safety profile looks like for inhaled botanical cannabis.

Has cannabis shown any promise as a treatment for PTSD?

We have had mixed results in the pilot study that we conducted previously, but we think the cannabis supply was part of the issue. If we had observed a large effect size in that pilot study, we would have gotten significant results.

What’s was the problem with the sample?

The THC percentage was low. According to the University of Mississippi’s certificate of analysis, it was 12 percent THC; but when we sent it out for independent testing, we found that it could be as low as 9 percent. As I understand it, the processing of the cannabis can also have an influence on the overall quality. We also think that it was possibly low in potency because, as I understand it, there were multiple plants of varying strains and genetic backgrounds that were ground up and put into a blender. In the end we don’t really know what other cannabinoids were present in that cannabis originally.

The new supply, which we’re going to import from international sources, will have a full cannabinoid profile, known to us as a part of the certificate of analysis. And we’ll also have a full understanding of what terpenes are involved. So with better information and fresher material, we think that we might be able to have a better chance of observing a difference between high THC and placebo, if one does exist.

What specific PTSD symptoms does it seem to help with?

We have some promising data on sleep quality improvement from the pilot study—specifically with the high THC group—that we think is worth pursuing. There’s a big connection between sleep quality and PTSD, because PTSD is essentially a mind-body condition that is affecting one’s ability to process memories. That memory processing happens during sleep. So if a patient’s sleep is very poor quality, it really influences the severity of their PTSD symptoms. If a patient is going to respond to a PTSD treatment, you would expect that their sleep quality would improve as well. We’re going to be doing very detailed sleep measurements in our study.

Then the other thing that comes along with having PTSD is suicide risk. The whole point of this grant from the state of Michigan was to study factors that contribute to suicide risk and veterans—and suicide risk is very, very high. When somebody has PTSD, it’s one of the main predictors of suicide risk, in veterans and otherwise. So if we can measure changes in suicide risk, then we also have pretty good odds of seeing a difference on the PTSD scales.

How long will it be before we see the results?

It will probably be a couple years. We’re just in the process of getting all of the players who will be supporting us in this clinical trial on-boarded. We have some hiring to do with the grant funds. We need to build out a cannabis team within the MAPS Public Benefit Corporation, which is the research arm of maps. That is gonna probably take several months. Then the study plans to start early next year. Then we would be analyzing the data and hopefully having some results to share in 2024.


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