Are you interested in participating in a psychedelic clinical trial? Studies are now enrolling heathy participants and individuals with specific health conditions. Search the map or list below by psychedelic substance, location, health condition, and study status. Enroll today in psychedelic research trials!
You could be eligible to participate in a psychedelic clinical trial for 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.
Psychedelic Clinical Trials Database
Browse our clinical trials database and filter by substance, location, condition, and enrollment status. Studies are displayed on a map and list.
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):
|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 pain|
|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 drugs that lack the hallucinatory effects but could have therapeutic potential.
How a Psychedelic Clinical Trial Works
A psychedelic clinical trial collects data to evaluate safety and efficacy of drugs under investigation in research. Drugs must pass through a sequence of phases or stages to become 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, sometimes an already known drug like some psychedelics, can go through less animal testing or wait till later in the process to complete.
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 to reduce symptoms. Phase 2 studies can be open-label or randomized controlled trials. The number of participants can range from very small to hundreds. Phase 2 trials provide information about frequency of 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 signals the potential to be 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 or disease, 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. This is known as post marketing surveillance trials. Phase 4 trials collect data on long-term effectiveness and safety. And they also study costs associated with treatment compared to other drugs on the market, and safety and effectiveness of the new drug versus other available 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 works, 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?
MAPS Public Benefit Corporation, a fully-owned subsidiary of MAPS, is sponsoring trials for MDMA-assisted therapy for 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 the unmet needs of patients.
MindMed discovers, develops, and deploys psychedelic-inspired medicines to improve health, promote wellness, and alleviate suffering.
Awakn Life Sciences is developing a better solution to treat addiction: psychedelic therapeutics – drugs and therapies used in combination. Awakn is a biotechnology company researching, developing, and delivering these therapeutics.
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. Several other public and private companies are involved in drug discovery, psychedelic research, and manufacturing. Except for MDMA, 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. Soon after, many other Universities announced new centers. Here is a current list of psychedelic-focused academic initiatives:
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 sponsor’s website. The study site usually has a short online screening form to see if you might potentially qualify.
From there, the study team staff will do a phone interview and invite you to an in person screening visit for further evaluation to see if you match the trial’s inclusion/exclusion criteria. Be sure to ask questions and understand the requirements for participation.
This post was originally published in July 2018 and has evolved through the years as the field has developed.