Though ketamine is currently the only clinician-prescribed psychedelic medicine available, that does not mean it’s the only one being researched and studied in a variety of treatment areas.
There are a number of psychedelic compounds and treatment methodologies moving through the psychedelic pipeline right now, including some additional novel and off-label uses for ketamine.
For those who feel like they may benefit from the therapeutic uses of compounds currently limited to research, the only avenue currently available to participate in these experiences is through volunteering for psychedelic research studies.
What Medicines Are Used in Psychedelic Research Studies?
There are a number of different medicines being tested and researched right now, and all are at various steps of the clinical trial process. These do not include active studies on cannabis and the cannabinoid system.
MDMA therapy is currently being spearheaded by the Multidisciplinary Association for Psychedelic Studies (MAPS) as a novel treatment for treatment-resistant post-traumatic stress disorder (PTSD).
It is currently entering Phase 3 clinical trials under a ‘Breakthrough Therapy’ designation from the FDA. This means that the results indicate the treatment likely offers substantial improvement over currently available therapy, that the FDA is contributing additional resources to help expedite the process of Phase 3 clinical trials, which can require great financial and time investments.
Psilocybin, the psychoactive ingredient in mushrooms with psychedelic properties, is also moving through a range of studies for various uses. This includes treatment-resistant depression, managing end-of-life anxiety in cancer patients, alcohol-related substance use disorder (SUD), and more.
Select psilocybin studies from COMPASS Pathways and Usona Institute have also received “Breakthrough Therapy” designation from the FDA — granting further resources to help the clinical trial process move forward faster. Early results have been significantly promising when compared to existing medical interventions.
Ketamine is often prescribed off-label in the treatment of depression and anxiety as its utility in this capacity is widely supported by research. It is FDA approved for treatment resistant depression and major depressive disorder with acute suicidal ideation or behavior,
Some areas of application being studied further are for treatment-resistant depression, suicidal ideation, and in the treatment of PTSD.
MDMA, Psilocybin, and Ketamine are among the most heavily invested in and studied medicines undergoing clinical trials. There are additional compounds that are actively being researched for potential use cases, safety profiles, and efficacy.
Lysergic acid diethylamide (LSD), Ibogaine, and Ayahuasca all have potential clinical and therapeutic use-cases. Due to factors such as the nature of the experiences, the length of duration, and the variability in preparation or isolation of the compound, these medicines are more difficult to arrange clinical trials for. However, early evidence for these compounds is pointing to their valid medical or mental health applications, including PTSD, smoking cessation, and other substance use disorders.
Who Runs Psychedelic Research Studies?
Given that a majority of the medicines undergoing clinical research studies are Schedule 1 controlled substances by the DEA, only select authoritative and accredited universities, companies, or organizations are able to work with these compounds. This is done under strict regulatory and safety guidelines.
If you are interested in participating in one of these studies, you will have to register and be found eligible through the organizations themselves. There are a number of groups running trials, and a number of trials available at each location. Psychedelic.Support, a home for psychedelic therapists and resources, offers a comprehensive list of the various trials available for each medicine.
As the bastions of continuing education and research, scientists at many universities are running studies on various use-cases for different psychedelic compounds. Universities like Johns Hopkins, NYU, and more, have opened dedicated research arms for psychedelic studies, pioneering research for potential applications.
There are a few private companies who are developing these compounds and medicines, while initiating or facilitating complimentary research studies. Companies like COMPASS Pathways, ATAI Life Sciences, and others have research studies available through their websites.
Non-profit organizations & institutes
There are a number of non-profit organizations or psychedelic institutions that are pioneering research and clinical trials in psychedelic medicines. This includes esteemed groups like MAPS, the Heffter Institute, Usona, the Beckley Foundation, and more.
Referring to ongoing studies on their websites can help locate available opportunity and eligibility criteria.
ClinicalTrials.Gov is also a fantastic resource for anyone looking for condition or compound-specific studies currently underway and actively recruiting new participants.
Am I Eligible for Psychedelic Research Studies?
An important point of consideration when looking into psychedelic research studies is eligibility. Because these studies are focused on very specific conditions or medical use-cases, most of the studies are looking to enroll very specific client profiles.
Eligibility criteria can include:
- Specific age ranges
- Specific medical/clinical diagnosis
- Location and availability
- Treatment-resistant designations
If you have found a research study that looks like it’s right for you, make sure you check for the specific eligibility criteria. Given the specific focus on the studies, organizations are unlikely to be lenient with these criteria.
What Conditions Are Being Studied?
There are a wide variety of conditions being studied and explored currently. The majority of studies focus on the management and resolution of treatment-resistant cases of mental health conditions. Some of the conditions being researched include:
- End-of-life anxiety
- Treatment-resistant depression
- Major Depressive Disorder
- Suicidal ideation
- Substance Use Disorders
- Eating disorders
These will change depending on the organization and the research group conducting the studies, but those studies that are largest and furthest along tend to address one of the above conditions.
Risks & Considerations in Psychedelic Research
As with any ongoing research or studies, these medicines and applications are actively being researched. They are being researched for efficacy, safety, and overall results based on specific variables. Given this, there are a number of considerations to take into account before enrolling in a research study.
- Safety: Given that most clinical trials open to public participation are in Phase 2 or Phase 3 (they have passed the basic safety trials), there are still unknown variables. Your unique health and safety needs should be considered before enrolling and discussed with researchers.
- Efficacy: The goal of these studies is often to determine efficacy and use cases, so there are no guarantees that the condition you are suffering from will be resolved or improved. It even has the potential to get worse, which depending on your condition, is worth extra consideration.
- Investment: You often don’t need to pay to participate in these studies, but there will be a level of emotional and time investment in these studies. Psychedelic therapy protocols can involve therapy sessions, and can extend for weeks or even months. Depending on the study design, there is also the chance that you will get a placebo and not the desired treatment which is important when factoring in time investment and your healing journey.
What Countries Have Psychedelic Research Studies?
The countries that are available to you when considering enrolling in psychedelic research studies are limited across two factors: the legal status/availability of the medicines, and the location of the organizations running the studies ie., where they have their clinical sites set up.
Going from the list of organizations mentioned above, most of these studies are available in the US, UK, Canada, or Israel.
The early results from psychedelic research and ongoing ketamine treatments show promising indications to the efficacy of these treatments. Multiple compounds in trials have received Breakthrough Therapy and Fast Track designations from the FDA.
Participating in clinical research trials have the potential to not only receive assistance and medication to improve your own health and wellbeing, but also contribute to ground-breaking research and help push these medicines towards public accessibility for those who need them most.
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This article is for informational purposes only and is not intended to be a substitute for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. If you are in a life-threatening situation, call, text, or chat the National Suicide Prevention Line at 988 or +1 (800) 273-8255, call 911, or go to the nearest emergency room.
Important FDA Safety Information
Ketamine is not FDA-approved for the treatment of depression or anxiety. Learn more about off-label uses here.
Side effects of ketamine treatment may include: altered sense of time, anxiety, blurred vision, diminished ability to see/hear/feel, dry mouth, elevated blood pressure or heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses).
Do not proceed with ketamine treatment if any of the following apply to you:
- Allergic to ketamine
- Symptoms of psychosis or mania
- Uncontrolled high blood pressure
- CHF or other serious heart problem
- Severe breathing problem
- History of elevated intraocular or intracranial pressure
- History of hyperthyroidism
- Other serious medical illness
- Pregnant, nursing, or trying to become pregnant
Ketamine has been reported to produce issues including, but not limited to, those listed below. However, lasting adverse side-effects are rare when medical protocols are carefully followed.
While ketamine has not been shown to be physically addictive, it has been shown to cause moderate psychological dependency in some recreational users.
- In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
- Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders.
- Users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your MindBloom® clinician before proceeding with treatment.
- The dissociative effects of ketamine may increase patient vulnerability and the risk of accidents.
To promote positive outcomes and ensure safety, follow these ketamine treatment guidelines:
- Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep
- Refrain from taking benzodiazepines or stimulants for 24 hours prior to treatment
- Continue to take antihypertensive medication as prescribed
- Avoid hangovers or alcohol intake
- Refrain from consuming solid foods within 3 hours prior to treatment and liquids within 1 hour prior to treatment
- Ketamine treatment should never be conducted without a monitor present to ensure your safety