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Fundamentals of Research
The Importance of Study Design
To truly understand the effects of psychedelics, it’s vital to consider the design of the studies examining them. One of the gold standards in scientific research is the double-blind randomized controlled trial (RCT). In such studies, participants are randomly assigned to receive either the psychedelic or a placebo, and neither the participants nor the researchers know which one is being administered. This “blinding” is crucial because it helps to prevent bias—a tendency for results to be skewed by researchers’ or participants’ expectations.
Randomization further reduces the risk of selection bias, which occurs when certain types of participants are more likely to be assigned to one group than another, potentially distorting the results. By randomizing, researchers ensure that the groups are comparable, and any differences in outcomes can be more confidently attributed to the psychedelic itself rather than other factors.
Another critical aspect of evaluating scientific evidence is recognizing the potential for publication bias. This bias occurs when studies with positive results are more likely to be published than those with negative or inconclusive outcomes. As a result, the published literature may present an overly optimistic view of the efficacy of psychedelics.
Therefore, in our overview above, we prioritized results from systematic reviews. These reviews critically assess and synthesize all available studies on a given topic, offering a clearer picture of the overall evidence. We prefer reviews that adhere to rigorous guidelines such as those established by Cochrane or PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). These guidelines ensure that the reviews are conducted with strict attention to scientific criteria, including the quality of study design, risk of bias, and the consistency of findings across different studies.
Challenges in Psychedelic Research
Conducting rigorous research on psychedelics presents several unique challenges. One of the primary difficulties is maintaining the double-blind study design, which is the gold standard in clinical research. The profound and unmistakable effects of psychedelics make it almost impossible to prevent participants and researchers from knowing who has received the active substance versus a placebo, leading to potential bias in the results.
Additionally, many psychedelic studies suffer from small sample sizes, which limit the generalizability of the findings. Recruiting participants willing to undergo a potentially intense psychedelic experience, especially within the strict protocols of a clinical trial, can be challenging. Also, because of ethical and legal restrictions. The Schedule I classification of many psychedelics in various countries places significant regulatory hurdles on researchers, requiring special permissions and limiting access to these substances.
Moreover, the high cost of psychedelic research, particularly in bringing substances through the full clinical trial process, poses another significant obstacle. Even more so with natural substances, as the lack of patentability of natural substances like psilocybin limits interest from large pharmaceutical companies.
Despite these challenges, innovative approaches and growing public interest are gradually overcoming these barriers, allowing for the continued advancement of psychedelic science.
Why Double-Blind Studies Are (Hilariously) Difficult in Psychedelic Research
As mentioned, in modern science, the double-blind randomized controlled trial is considered the gold standard.
But when it comes to psychedelic research, there’s a slight problem.
Imagine this: You’re a participant in a study testing psilocybin for depression. You’re handed a pill and asked to sit quietly while the effects kick in. Now, an hour later, one participant is gazing in awe at the wallpaper, convinced it’s a portal to another dimension, while another is politely asking if they can go home because they feel absolutely nothing. It doesn’t take a genius to figure out who’s on the psilocybin and who’s on the placebo.
This presents a unique challenge for researchers. The whole point of a double-blind study is to prevent participants and researchers from knowing who got what, but when your research involves substances that can make you see sounds and taste colors, the cat is out of the bag pretty quickly.
Absence of evidence is no evidence of absence
While we deeply value scientific standards and strive to base our claims on rigorously validated research, it’s important to clarify that the absence of conclusive evidence does not necessarily mean that certain effects or outcomes are untrue. In the scientific community, “no evidence” simply means that a hypothesis has not yet been proven, not that it has been disproven. There are many promising indications in psychedelic research that, while not yet fully confirmed by all scientific standards, show potential benefits based on early findings and anecdotal reports. We approach these indications with cautious optimism, recognizing their potential while also acknowledging the need for further research. Our commitment to scientific integrity means we will continue to monitor these developments closely, balancing our enthusiasm with a careful, evidence-based approach.
Value of empirical evidence
In addition to our commitment to scientific rigor, we also place significant value on anecdotal and empirical evidence. We believe that real-world experiences and feedback can provide important insights, even if they don’t meet the strict standards of scientific research. For instance, results from our own surveys consistently show that participants highly rate the programs, reporting strong positive transformations in their lives. Other studies have also shown that guided experiences with psilocybin were considered by participants to be among the most personally meaningful and spiritually significant of their lives (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3050654/).
While these testimonials and survey results may not carry the same weight as peer-reviewed studies, they do align with our expectations and reinforce our belief that our programs have a meaningful impact on people’s well-being. This feedback not only validates our work but also motivates us to continue refining and expanding our offerings to better serve our community.
Transformational vs Medical
Psychedelic research has largely focused on individuals with specific mental health conditions, often conducted under the close supervision of medical professionals. At Spinoza, our approach centers around preventive health and holistic transformation. Nevertheless, we believe it is crucial to learn from the ongoing medical research in the field. By understanding the safety protocols, therapeutic techniques, and psychological insights emerging from clinical studies, we can apply these lessons to enhance the efficacy and safety of our transformative sessions, ensuring a more profound and beneficial experience for our clients.