How To Join a Psychedelic Clinical Trial

How do I join a psychedelic clinical trial?

To join a psychedelic clinical trial, start by researching opportunities through platforms like ClinicalTrials.gov, research institutions, or pharmaceutical company websites. You must meet specific eligibility criteria, which often include certain medical or mental health conditions, and agree to follow the study’s protocols. After applying, you may undergo a screening process with health assessments to determine your suitability. Participation offers access to cutting-edge therapies with careful professional oversight. Be sure to understand the risks and procedures involved before joining. By meeting the criteria and applying through the appropriate channels, you can participate in a trial and contribute to psychedelic research.

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Are you interested in participating in a psychedelic clinical trial? Studies are now enrolling participants with specific health conditions. Search the map below or list below by psychedelic substance, location, health condition, and study status. Enroll today in a psychedelic research trial!

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You could be eligible to participate in a psychedelic clinical trial for the purpose of research. Psychedelic studies, in various stages, enroll both healthy volunteers and individuals with specific mental health conditions. Below is an up-to-date and searchable compilation of psychedelic clinical trials registered on clinicaltrials.gov.

When you find a study location in your area that you may be a fit for, contact the study sites through the listings in the clinical trial records provided below. You can also find more information about enrollment on clinical trial sponsors’ websites or clinical registry sites by country.

Psychedelics Under Study

Several psychedelic substances are now under study to see if they can be effective and safe for treating mental health conditions. MDMA is furthest along in the development pathway, followed closely by psilocybin. In the past few years, the list of drugs and compounds has steadily grown. The research is still very early for most psychedelics, but initial findings are very promising. Here is an overview of psychedelic substances and conditions in clinical trials (or planned):

Substance	Conditions
MDMA	post-traumatic stress disorder, alcohol use disorder, eating disorders, social anxiety, anxiety related to a life-threatening illness
Psilocybin	major depressive disorder, treatment-resistant depression, alcohol use disorder, nicotine dependence, headache disorders, palliative care, cocaine use disorder, methamphetamine use disorder, obsessive-compulsive disorder, chronic pain, phantom limb pain, provider burnout, eating disorders, fibromyalgia, body dysmorphic disorder, post-traumatic stress disorder
DMT	[planned] major depressive disorder
5-MeO-DMT	[planned] treatment-resistant depression, anxiety disorders, eating disorders, chronic painIbogaineopioid withdrawal, alcohol use disorder, addictionLSDmajor depression, cluster headachesMescalinealcohol use disorder
Ibogaine	opioid withdrawal, alcohol use disorder, addiction
LSD	major depression, cluster headaches
Mescaline	alcohol use disorder

Other drugs like ketamine and cannabis are being tested in many ongoing trials. Ketamine is available now through off-label prescriptions for mental health conditions. Cannabis access varies by state. There is also research into psychedelic-inspired compounds that lack hallucinatory effects but could have therapeutic potential.

How a Psychedelic Clinical Trial Works

A psychedelic clinical trial collects data to evaluate the safety and efficacy of drugs under investigation in research. Drugs must pass through a sequence of phases or stages to become government-approved and available to patients.

Preclinical — Nonhuman Toxicity and Dose-Finding Studies

A new substance is first thoroughly tested in human cells and/or animals to gain initial information about safety and toxicity. If enough research exists in scientific journals or if the drug is already familiar to researchers, sometimes it can undergo less animal testing or wait until later in the process to complete the full battery of nonclinical toxicology tests.

Phase 1 — Safety Trials for Healthy Volunteers

After review, the FDA can grant approval to test the drug in a small number of healthy individuals (phase 1). The study is designed to evaluate safety and identify the dosing range. Dose escalation studies are common where 2-4 participants receive the lowest dose, and if well tolerated, the next set of volunteers receive a higher dose.

Phase 2 — Safety and Efficacy Trials for Patients with a Condition

The next phase of testing involves giving the investigational treatment to patients who have a disease or condition (phase 2) to evaluate safety and effectiveness in reducing symptoms. Phase 2 studies can be open-label (no placebo or comparator drug) or randomized controlled trials. The number of participants can range from very small (for example, 10 to 20) to hundreds. Phase 2 trials provide information about side effects, dosing range, symptom measurement, and efficacy—all necessary for planning well-designed phase 3 trials.

Phase 3 — Pivotal Trials for Patients with a Condition

If the drug appears safe and shows potential as a useful treatment, then a much larger number of participants are tested in phase 3 trials at multiple study sites. For the Food and Drug Administration (FDA) to approve a new drug for a specific condition, two phase 3 trials must show significant benefit that outweighs the risks or negative side effects of taking the drug.

Post-Approval Trials — Safety Surveillance and Long-term Effectiveness

After approval, the drug is sold in the consumer market through prescriptions by medical personnel. Research continues in phase 4 of the psychedelic clinical trial, which is known as post-marketing surveillance trials. Phase 4 trials collect data on long-term efficacy and safety. They also study the costs associated with treatment, as well as safety and effectiveness. They then compare this to other drugs on the market and already existing treatment options. 

Psychedelic Clinical Trial Forerunners

Research around the world is expanding quickly. New investigations for the therapeutic use of psychedelics, as well as inquiries into how the brain and consciousness work, are appearing all the time.

The forerunners in this field have paved the way for others by contributing evidence-based findings to the body of knowledge. Much credit is due to the pioneering non-profit organizations for their decades of work to reignite interest in psychedelic research and raise funding to support it. These include the Multidisciplinary Association for Psychedelic Studies (MAPS), Heffter Research Institute, and the Beckley Foundation. The Usona Institute, founded more recently in 2014, conducts pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Now, several organizations, academic institutions, and corporations are leading the psychedelic clinical trial and research field forward.

Who are the Leaders in Drug Development?

• Lykos Therapeutics (formally known as MAPS Public Benefit Corporation) is sponsoring trials for MDMA-assisted therapy for PTSD and other various anxiety-related conditions.

• COMPASS Pathways is a mental health care company conducting psilocybin clinical trials in Europe and North America for treatment-resistant depression, PTSD, and other mental health conditions. 

• Atai Life Sciences is a biopharmaceutical company that leverages a decentralized platform approach to incubate and accelerate the development of highly effective mental health treatments that address patients’ unmet needs. 

• MindMed discovers, develops, and deploys psychedelic-inspired medicines to improve health, promote wellness, and alleviate suffering.

• Cybin is developing next-generation mental health treatment options with a proprietary psilocin formulation to treat major depressive disorder and a DMT therapeutic to treat genearalized anxiety disorder.

• Numinus Wellness combines the latest advances in psychedelic medicine with the best in evidence-based care and a holistic, integrated approach to healing. Numinus is participating in compassionate access trials for MDMA and psilocybin in Canada. 

• Gilgamesh Pharmaceutical is a neuroscience biotech company developing novel compounds that target neurological diseases. In partnership with institutions like Columbia University, Gilgamesh is creating ibogaine analogs and other psychedelic-inspired compounds that act on the 5-HT2 receptors. 

Several other public and private companies are involved in drug discovery, psychedelic research, and manufacturing. Except for MDMA and psilocybin (phase 3), all other psychedelic substances are either in preclinical development, phase 1 or 2 trials.

Academic Psychedelic Research Centers

In 2019, the first modern-day academic research center specializing in psychedelics was officially established at the Imperial College of London. Soon after, many other universities announced new centers. Here is a current list of psychedelic-focused academic initiatives:

• Imperial College of London, Centre for Psychedelic Research 

• Johns Hopkins University, Center for Psychedelics & Consciousness Research 

• University of California San Francisco, Neuroscape

• University of Texas at Austin, Dell Medical School, Center for Psychedelic Research & Therapy

• Massachusetts General Hospital, Center for the Neuroscience of Psychedelics

• University of California Berkeley, Berkeley Center for the Science of Psychedelics

• New York University, Grossman School of Medicine, Center for Psychedelic Medicine

• University of Wisconsin, Transdisciplinary Center for Research in Psychoactive Substances

• Mount Sinai Icahn School of Medicine, Center for Psychedelic Psychotherapy and Trauma Research

• Naropa, Center for Psychedelic Studies

• California Institute of Integral Studies, Center for Psychedelic Therapies and Research

All over the world, at both academic research institutions and through commercial pharmaceutical companies, psychedelic substances and novel psychedelic-inspired compounds are being explored for both mental and physical health conditions, from anxiety, addiction, and trauma, to even chronic pain and brain injury. This type of government-approved research, bringing new medications to market, may revolutionize therapy and the drug market with tools that may be proven more efficacious than the current set of psychiatric drugs on the market. 

Participate in Clinical Trials

If you are interested in joining a psychedelic clinical trial, contact a study site in your area. You can find contact information on the clinicaltrials.gov record or by visiting the study sponsor’s website. The study site usually has a short online screening form to see if you might qualify.

From there, the study team staff will conduct a phone interview and invite you to an in-person screening visit to evaluate whether you match the trial’s inclusion/exclusion criteria. Be sure to ask questions and understand the participation requirements. 

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This post was originally published in July 2018 and has evolved through the years as the field has developed.