The opportunity to play a role in a process that can shift how society views something doesn’t come around too frequently. But thanks to a renewed interest in psychedelics, participating in a clinical trial can do just that.
Since most psychedelics are currently illicit substances, one of the few ways to access legal psychedelics is through participation in a clinical trial, which are studies that research new treatments and their potential effects on human health.
If you’re one of the thousands of people interested in joining a psychedelic clinical trial, following three steps can help you get there—looking for studies, determining your eligibility, and understanding what you’re signing up for.
Importance of Clinical Trials
If you’ve seen psychedelics in the news recently, read about them in a book, or seen evidence of psychedelic use in American pop culture, you have clinical trials to thank. From songs that mention shrooms to attempted IKEA furniture building while on LSD, psychedelics have once again become something regularly discussed in our society.
This wouldn’t have been possible without a group of dedicated researchers and enthusiasts—and clinical trials have kept psychedelics relevant after they all but disappeared from public view due to heightened restrictions beginning in the 1960s.
In the United States, clinical trials are conducted in different steps, referred to as “phases.” From Phase I to Phase IV, the drug in question goes through a series of research trials with an increasing number of participants.
The ultimate goal is to be approved by the FDA and made available to the public. Without clinical trials, psychedelics would have never made it to where they are now—well on their way to becoming legitimized as therapeutic tools with tremendous healing potential. But before we outline three actionable steps to join a clinical trial, let’s explore the intricate history of psychedelics in clinical trials.
An Interesting History of Psychedelic Clinical Trials
Despite the fact that we’re currently in the midst of a psychedelic renaissance, psychedelic drugs have had historical significance for hundreds of years across the world. And in the mid 1900’s, psychedelics in America underwent an important period of research and discovery.
Between 1950 and 1970, LSD alone was featured in more than 1,000 published reports and was tested in clinical trials with more than 40,000 patients. Psychedelics were studied extensively for their benefits in being combined with psychotherapy to reduce symptoms of anxiety, depression, alcoholism, and other psychiatric disorders. This all came to a halt, however, during the War on Drugs.
The prohibition of psychedelics and a resulting curtail of research started in 1966 and was driven in many ways by the fear and stigmatization that came about during a time where more people were experimenting with these ‘mind manifesting’ substances.
Everything really came to an end in 1970, when President Nixon signed the Controlled Substances Act, which made LSD and psilocybin Schedule I drugs, which are defined as having no medical or therapeutic use with a high rate of addiction. Today, the majority of psychedelic substances are Schedule I, with some, like ketamine, having lesser restrictions at Schedule III.
Psychedelic Research Revival
Over the past few decades, countless clinical trials have been facilitated and billions of dollars have been invested—yet we’re still faced with climbing rates of mental illness and a treatment-resistant segment of the population that aren’t responding to current, approved medical treatments.
Research into psychedelics like DMT and psilocybin began again in the 1990s and it is now being recognized as an area of psychological research that may provide a solution to the mounting mental illness problems faced in the United States.
Current clinical trials have been completed using psychedelics like MDMA, ayahuasca, ketamine, psilocybin, ibogaine, and LSD, to name a few. Recent clinical trials have been successful in moving both psilocybin and MDMA through the various phases.
In 2019, the FDA designated psilocybin therapy a “breakthrough therapy” twice. This expedites the development and review process, meaning that psilocybin could complete Phase 3 trials over the next couple of years and be released for public use shortly after.
Moving along the regulatory path just as quickly, MDMA is currently being used in two Phase 3 trials and is also considered a “breakthrough therapy.” MDMA has received a special protocol assessment, or a written agreement, that efficacy in Phase 3 trials will mean FDA approval. MAPS is running the studies and anticipates having the drug FDA approved to be used as a prescription medicine by 2021.
How Do I Join a Psychedelic Clinical Trial?
These are very exciting times for psychedelics and the research using them. Recent clinical trials have demonstrated the many benefits that psychedelics have in treating mental illness and new research opportunities are regularly being promoted. If you’re one of the many people interested in not only contributing to this fascinating area of science, but also taking advantage of an opportunity to potentially experience a psychedelic and its healing properties for yourself, now is a great time to do so.
Wondering how to join a psychedelic clinical trial? Here are three steps to follow.
1. Look for Studies
The first step in your journey is to do a bit of research. You may be surprised to find that there are many ways you can get involved in psychedelic clinical trials—through funding, self-report studies, or even actual participation.
Clinicaltrials.gov
In terms of experiential research (actually participating in a study with psychedelics or a placebo), you’d have most luck exploring the clinicaltrials.gov database. From their homepage, you can simply input psychedelics into the ‘Other Terms’ search field and get an idea of what’s offered.
The results will include all studies for all conditions, with all psychedelics and in all participating countries—although these search results can be filtered depending on your location, condition, and interest. Additionally, you can use the search feature to only search studies that are either currently recruiting or will be in the future.
The Multidisciplinary Association for Psychedelic Studies
The Multidisciplinary Association for Psychedelic Studies, or MAPS for short, has been one of the most predominant forces in the recent resurgence of psychedelic research. They’re the non-profit research and educational organization that is currently involved in the Phase 3 MDMA assisted psychotherapy study.
They have been involved in previous clinical trials involving LSD and medical marijuana, as well as observational studies with ibogaine. They have also supported research of ayahuasca assisted treatment.
At the time of writing MAPS is sponsoring studies currently recruiting volunteers for two clinical trials using MDMA, as well as one survey study for participants who have previously used ayahuasca. Exploring their website will not only give you more information on the organization, but also details on their clinical trials and how you can support or participate.
Johns Hopkins Center for Psychedelic and Consciousness Research
In 2000, Johns Hopkins was the first research group to obtain US regulatory approval to begin psychedelic research again. Ever since then, they have been at the forefront of psychedelic research and have published more than 60 peer-reviewed articles about psychedelics.
Their current research explores psilocybin and a range of conditions, including depression, Alzheimer’s, and anorexia nervosa—to name just a few. Electronic surveys can be accessed on their website to determine eligibility. On their website you can sign up for their newsletter, where they will share latest news and information on upcoming studies.
Usona Institute
The Usona Institute is a medical research organization that was founded with a goal to assist individuals with depression and anxiety for whom current medical treatments have fallen short. They utilize psilocybin and other consciousness-expanding medicines to conduct clinical and pre-clinical research.
With the ultimate goal of FDA recognition of psilocybin as an approved medicine, the Usona Institute is currently recruiting volunteers with Major Depressive Disorder for Phase 2 clinical trials. They received breakthrough therapy designation from the FDA in 2019.
Other Organizations to Explore
There are many other organizations dedicated to furthering psychedelic research. These include university organizations like the UMASS Medical School Center for Mindfulness as well as advocacy groups like the Psychedelic Society of Minnesota.
While they won’t be directly conducting clinical trials, there are other helpful organizations to look into. These include the Heffter Research Institute, Entheogenic Research Integration and Education, and The California Institute for Integral Studies Center for Psychedelic Therapies and Research.
We understand that this is a long list of organizations and it could take weeks to look through all of them to find a suitable clinical trial. You may also have questions about whether a clinical trial is right for your preferences and specific needs. And even if you identify the right trial, you may not be selected to participate.
Don’t let these roadblocks inhibit your psychedelic journey of healing. If you’re interested in getting help with joining a clinical trial or learning more about other alternatives, setting up a call with a psychedelic coach is one click away.
2. Determine Your Eligibility
The next step after exploring different psychedelic clinical trials is to determine your eligibility for them. In some cases, expressing interest in a clinical trial will involve completing an online form that will determine your suitability for participation. On the clinicaltrials.gov database, the eligibility criteria will be listed with the rest of the study’s information.
In some cases, participation in a clinical trial will require that you meet specific diagnostic criteria, many times requiring that you’ve been diagnosed with a specific mental condition based on DSM-5 criteria. In some cases, you will have to demonstrate that you’ve failed adequately attempted routine care treatment. Interestingly, while some studies will require that you’ve never taken psychedelics before, others will actually require that you have taken psychedelics previously.
There are certain risks and benefits of participating in a psychedelic clinical trial. Not all studies have been evaluated by the US government.
Most clinical trials involve some inherent level of risk, and in the case of psychedelic research, you may receive a placebo—minimizing the potential for accessing the healing benefits you may desire. It is strongly recommended that you speak with your health care provider before any participation, and also thoroughly vet any study you might decide to participate in.
3. Understand What You’re Signing Up For
More than 130 of the grants that allowed the studies during pre-prohibition psychedelic research were funded by the US government and its National Institutes of Health (NIH). However, since research ended in the 1960s, the NIH hasn’t provided any funding, even as clinical trials have been revived. Federal funding cannot be used for most types of psychedelic research, as researchers with Schedule I drugs are discouraged from even applying for federal funding.
Today, psychedelic clinical trials are mostly funded by private donors, educational institutions, non-profits, and private companies such as pharmaceutical and biotech producers. The reason this is important to realize as a potential participant is that funding will come from an array of sources that all have different interests and agendas with psychedelic research. The source of funding for medical research has been demonstrated to impact the results—and this is something you should keep in mind when looking for a clinical study to participate in.
Burdensome costs are one factor researchers have continuously had to deal with, as is working with an illicit and federally prohibited drug. Not only is getting supplies extremely difficult, but it also requires significant time and financial investment. Until regulation changes, moving some psychedelic substances out of the Schedule I category, research will continue to be limited by these barriers.
The first modern clinical trial that involved a psychedelic took place in 2006 at the University of Arizona. It involved psychotherapy combined with psilocybin sessions with treatment-resistant OCD. While results appeared to be significant, the trials were reportedly stopped as the costs became too high.
So why does this matter to you? Because you may want to join a clinical trial to legally access the potential healing power of psychedelics, but may not even consume the drug (in the instance of a placebo) or have the study stop short due to a lack of funding. This is particularly troublesome for those who have committed a large amount of time and effort to participate, or those whose mental health diagnosis is reaching a critical and unsafe juncture.
Regardless of a Clinical Trial, Psychedelic Integration Matters
While it is a component of many psychedelic clinical trials, integration can be an effective way to make sense of an experience with psychedelics. A psychedelic integration specialist is a professional with firsthand experience with the substance who helps you prepare for and integrate lessons from the event into your daily life.
Integration is a crucial component of psychedelic therapy—and this goes for clinical trial participants too. Experience with a non-ordinary state of consciousness during a clinical trial will undoubtedly be a significant experience for trial participants. Having a professional to discuss this experience with can help a trial participant discover insights and assimilate these into long-term wellbeing.
While integration is typically a part of the clinical trial process, you have the option of seeking an integration specialist outside of the clinical trial, before as well as after the trial is over. There are innumerable benefits of a psychedelic experience—but the trip itself can be bewildering and indescribable until you work through the integration process. We also offer psychedelic trip sitting services in decriminalized areas.
We can help you harness all of the insights and give you the best chance to optimize the potential benefits. If you feel a calling to explore psychedelics for healing, we invite you to book a consultation with us.
If you are interested in joining a psychedelic clinical trial, now is the best time to do so. Thanks to the continued efforts of researchers around the globe we have entered a period of time in which science is beginning to recognize the value of psychedelics that indigenous cultures have been aware of for millennia.
With psychedelics like psilocybin and MDMA well on their way to being recognized as legal medical treatments—and with others sure to follow—now is a perfect time to get involved and be a part of this paradigm-shifting era.
