For some, thinking about LSD conjures visions of… visions… or Grateful Dead concerts and other hallmarks of the late ‘60s counterculture.
But more and more researchers are once again interested in the potential of psychedelic drugs to treat mental health conditions,
Last year, the U.S. Department of Veterans Affairs launched clinical trials focused on psychedelics. And this year, Vermont lawmakers considered decriminalizing magic mushrooms because of potential therapeutic benefits.
The Woodstock Research Center in Windsor County is studying whether LSD is a safe and effective treatment for Generalized Anxiety Disorder.
Vermont Public's Jenn Jarecki sat down with principal researcher Dr. Susan Smiga to learn more about her work. Their conversation below has been edited and condensed for clarity.
Jenn Jarecki: Can you start by telling us how this study came about and what questions your team is trying to answer?
Dr. Susan Smiga: We are not initiating the study. This is a study that's being started by a company called MindMed. They have selected a number of different sites around the country to implement the protocol, and we are one of those sites. This study is looking specifically at LSD in relationship to a condition called generalized anxiety disorder, and is what we call a dose finding or phase two study.
A phase two study is usually done with a more modest population to establish what dose might be most effective. And if it shows some effect or efficacy for the targeted disorder, in this case, anxiety — if this is a successful trial that shows that the medication is safe and well tolerated and suggests that it is effective, it would go on to be a phase three study which would be much larger. And we'd be comparing LSD or the identified drug that MindMed has developed against other standard of care medications and or placebo.
This study and other work that is happening with other hallucinogenic drugs is helping us understand how the mind works, and to have a better understanding of consciousness in general, which is what defines us as human beings. So beyond the treatment of specific psychiatric disorders, I think these substances, these drugs have the potential for us to expand our understanding of human thinking and human consciousness in a way that certainly the things that are available to us for these treatments currently does not.
Will you share with us the potential benefits of LSD over other treatments for generalized anxiety disorder?
Anxiety disorders are one of the most prevalent psychiatric disorders in in the country and in the world. The available treatments we have currently do not work for some 40% of those individuals. The treatments we have available, both psychopharmacologic drugs treatments, as well as therapies, are somewhat limited in their scope in terms of what they are trying to change within the brain. Whereas LSD and some of the other psychedelic drugs, I think, are really trying to alter the connectivity between different areas of the brain, which has a much more profound effect, from my perspective.
When we have certain emotional experiences, we tend to reinforce behaviors that are associated with those emotions, and can be kind of stuck in a rut with certain patterns. LSD and other psychedelic drugs can disrupt that pattern so that there can be new learning and more profound changes that we might have available from the current psychotropic medications available on the market.
Stepping back a little bit, of course, LSD is illegal. So I'm wondering, can you break down for us how this study is actually being conducted, and if possible, who's participating?
When there is a new drug under development, the company developing the drug can submit an application to the FDA for an authorization to use the drug and research. Though LSD is a compound that's been around for a long time, it can be modified by the companies that are studying it, and they can apply for their specific compound to the FDA for approval. In addition, because LSD is a schedule one medication, which in the past, define drugs as having no medical benefit and high risk for addiction, I have to obtain a specific prescribing authority to administer the drug even within the study.
In terms of the subjects, we are recruiting individuals, anywhere between the ages of 18 and 70. These are individuals who meet the diagnostic criteria for generalized anxiety disorder, which is determined as part of the process that the subject goes through here at the center.
There are certain inclusion and exclusion criteria and common to all protocols for clinical trials that look at specific factors that might make an individual appropriate for the study or not. An example of that in this particular case is if someone has had post-traumatic stress disorder; they are not included in this study to avoid the possibility that there would be an adverse effect for someone who has already had the experience of trauma in their life. In general, our main issue has been that many people have anxiety but do not necessarily meet the criteria for this specific disorder. They have shown interest in the study but have not qualified for the study.
I wonder, Susan, are there any misconceptions about LSD that you'd like to address?
I think there are many misconceptions. First and foremost is that it has no benefit from a psychiatric treatment point of view; I think there are many studies to suggest that there are benefits. The second is that it is a highly addictive substance, which it is not.
Beyond that are a lot of the myths around LSD, such as that it is something that can damage your DNA, that it stays permanently in your body, it can kill brain cells, there is a high risk of having a "bad trip," when in fact, these are myths. In general, people's experience with LSD is a sort of mind-opening experience that is often associated with an enhancement of positive emotions, a decrease in what we consider negative emotions such as fear and to show benefit in terms of people's sense of relationship to themselves and or to the world around them.
Following up on that, scientists in the '50s and '60s also researched LSD as a psychiatric treatment. Why did that work lose steam? And what's happened in the scientific community since then to cause researchers to take another look?
When LSD specifically was first developed in a laboratory, Sandoz Laboratory, it was years after its identification that it became clear that it had a hallucinogenic benefit. There were not the regulations that we see currently around the conduction of clinical trials and research. LSD was being freely distributed to researchers to see what they could do with the drug. I think there were close to 1,000 studies done with LSD at that time. Subsequently, the drug became available outside of the research lab and was being used for recreational purposes. At some point, I think the effects of the drug were perceived as in some ways threatening to the status quo. The government decided to take a very hard stance and to make LSD illegal. With that ended our ability to conduct research with with LSD.
In the last 20 years, there has been some increase in research around psychedelic and other dissociative drugs. Ketamine is a good example. Psilocybin has had the most profound explosion of research interest, with LSD being perhaps less well-studied in part because of the duration of action. When we conduct our trial here, the individual receives a single dose the day of their treatment and they are here with us for 12 to 13 hours to be sure that the experience with the LSD has come to its conclusion, and the person is safe to leave the clinic. Psilocybin, on the other hand, has a duration of action closer to four to six hours.
Well, that seems like a great segue to my last question, Susan, which is if research does show that LSD is a useful and safe treatment for anxiety, what would that actually look like in practice? How would we get from where we are today where the drugs prohibited to opening up access for Vermonters?
There would be several steps. One would be for the phase three trial to happen, which again, would be a much larger group of patients, probably with fewer doses being administered of the active compound. Possibly comparing it to other medications or therapies that are already considered the standard of care and to see and establish that it is at least as effective or more effective, or better in some way than the established treatments we already have.
If that were the case, then there would be efforts to create frameworks to provide the drug in controlled environments. That would be the the likely natural course in the use of LSD as a treatment for psychiatric conditions. What it would do in terms of the decriminalization and or legalization for recreational use — would be something outside the scope that I could comment on. Though, I became aware recently that, for instance, in Oregon that the possession of small amounts of LSD was decriminalized back in February of 2021.
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