Participating in a Psychedelic Clinical Trial: A Guide for Interested Parties

Are you interested in taking part in a clinical trial involving psychedelic substances? Participants in healthy states as well as those with a variety of health conditions are currently being recruited for studies. You can search for psychedelic substances using the map or the list below. Filter your results by location, health condition, and study status. Sign up for psychedelic research trials as soon as possible.

You might be able to take part in a clinical study being conducted on psychedelics for scientific purposes. Research on psychedelics is currently being conducted at various stages, and participants include both healthy volunteers and people with various mental health conditions. You will find a comprehensive list of psychedelic clinical trials that are registered on clinicaltrials.gov below, which is kept up to date and can be searched. gov

You can get in touch with the research facilities that are conducting the studies in your area by using the information that is listed in the clinical trial records that are provided further down on this page. You can also find additional information about enrollment on the websites of clinical trial sponsors or on sites that are country-specific clinical registries.

Psychedelics Under Study

Studies are currently being conducted on a number of psychedelic substances to determine whether or not they are capable of effectively and safely treating mental health conditions. On the road to development, MDMA is the compound that is the farthest along, followed closely by psilocybin. The number of drugs and compounds on the list has been steadily increasing over the past few years. The research on the majority of psychedelics is still in its very early stages, but the preliminary findings are very promising. The following is an outline of psychedelic substances and conditions that are currently undergoing clinical trials (or have planned to do so):

Substances Conditions MDMA PTSD, alcohol use disorder, eating disorders, social anxiety, and anxiety associated with a life-threatening illness are all examples of disorders that can cause anxiety. Psilocybin Obsessive-compulsive disorder, chronic pain, phantom limb pain, provider burnout, eating disorders, fibromyalgia, body dysmorphic disorder, post-traumatic stress disorder, major depressive disorder, treatment-resistant depression, alcohol use disorder, nicotine dependence, headache disorders, palliative care, cocaine use disorder, methamphetamine use disorder, obsessive-compulsive disorder, alcohol use disorder, nicotine dependence, palliative care, DMT [planned] major depressive disorder 5-MeO-DMT treatment-resistant depression, anxiety disorders, eating disorders, and chronic pain [planned] Ibogaine Withdrawal from opioids, disorders related to alcohol use, and addiction LSD major depressive disorder, headache clusters Mescaline alcohol use disorder

In addition to ketamine and cannabis, numerous other drugs are currently being investigated in clinical studies. Off-label prescriptions of ketamine are now being filled for patients suffering from mental health conditions. Access to cannabis varies significantly between states. There is also research being done on drugs that have been inspired by psychedelics but do not produce hallucinations and may instead have therapeutic potential.

A Breakdown of How Psychedelic Drug Tests Are Conducted

Data are collected during a psychedelic clinical trial in order to evaluate the efficacy and safety of drugs that are currently under investigation in research. In order for a drug to be approved and made available to patients, it must first proceed through a number of phases or stages.

Studies on animals and nonhumans to determine safety and appropriate dosages are called preclinical.

First, a new substance is put through extensive testing in human cells and/or animals in order to collect primary data on the substance's safety and toxicity. If there is sufficient research published in scientific journals, an already known drug such as certain psychedelics may be required to undergo fewer animal tests or may be allowed to wait until a later step in the process to be finished.

The first phase will consist of safety tests on healthy volunteers.

Following the completion of the review, the FDA may decide to grant approval for the drug to be tested on a limited group of healthy volunteers (phase 1). The purpose of the study is to determine the appropriate dosage range as well as assess the level of safety. It is common practice to conduct dose escalation studies, in which the first set of volunteers receives the lowest possible dose, and then, if that dose is well tolerated, the next set of volunteers receives a higher dose.

Trials to Determine the Efficacy and Safety of the Treatment in Patients Who Already Have a Condition Phase 2

The investigational treatment will be administered to patients who already have a disease or condition in the subsequent phase of testing (phase 2), which will evaluate its efficacy in terms of reducing symptoms as well as its safety. Open-label or randomized controlled trials are both acceptable formats for phase 2 studies. The amount of people taking part can range anywhere from a very small number to hundreds. Information regarding the frequency of adverse effects, the dosing range, the measurement of symptoms, and the effectiveness is provided by phase 2 clinical trials. Everything required for the planning and design of effective phase 3 trials  

The pivotal trials for patients with a condition are conducted during the third phase.

If the drug appears to be safe and shows signs of having the potential to be an effective treatment, then the phase 3 trials are conducted with a significantly larger number of participants at multiple study sites. In order for the Food and Drug Administration (FDA) to grant approval to a new drug for the treatment of a particular disease or condition, two phase 3 clinical trials need to demonstrate that the potential benefits of using the drug significantly outweigh any potential drawbacks or risks associated with using the drug.

Trials Conducted After Product Approval to Evaluate Its Long-Term Effectiveness and Safety

After receiving regulatory approval, the medication is made available to customers via prescriptions written by healthcare professionals. The psychedelic clinical trial is currently in phase 4, where research is continuing. Post-marketing surveillance trials are another name for these types of studies. Data on long-term efficacy and safety are gathered during phase 4 clinical trials. In addition to this, they investigate the costs associated with the treatment in comparison to those of other drugs currently available on the market, as well as the safety and effectiveness of the new drug in comparison to other treatment options.

Forerunners of Psychedelic Treatment in Clinical Trials

The scope of research being conducted all over the world is rapidly increasing. There is a constant influx of fresh research into the potential therapeutic applications of psychedelic substances, as well as investigations into the operation of the brain and consciousness.

The pioneers in this field have paved the way for subsequent researchers by adding findings that are supported by evidence to the existing body of knowledge. For their tireless efforts over the course of several decades to rekindle interest in psychedelic research and secure funding to support it, the pioneering non-profit organizations deserve a significant amount of credit. The Multidisciplinary Association for Psychedelic Studies (MAPS), the Heffter Research Institute, and the Beckley Foundation are some examples of these organizations. The Usona Institute was established relatively recently in 2014, and its mission is to advance our understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines through the conduct of pre-clinical and clinical research. The field of psychedelic clinical trials and research is currently being led forward by a number of different organizations, academic institutions, and corporations.

Who Are the Most Prominent Leaders in the Development of Drugs?

Trials of MDMA-assisted therapy for a variety of anxiety-related conditions are being sponsored by MAPS Public Benefit Corporation, a wholly-owned subsidiary of MAPS.

COMPASS Pathways is a company that specializes in mental health care and is currently conducting clinical trials of psilocybin in Europe and North America for the treatment of treatment-resistant depression, post-traumatic stress disorder (PTSD), and other mental health conditions.  

Atai Life Sciences is a biopharmaceutical company that uses a decentralized platform approach to incubate and accelerate the development of highly effective mental health treatments that address the unmet needs of patients. These treatments are designed to meet the needs of patients who currently have no other treatment options.  

Medicines that are inspired by psychedelic experiences are being researched, developed, and distributed by MindMed in an effort to ameliorate suffering, improve health, and promote wellness.

A better treatment for addiction is currently being developed by Awakn Life Sciences. This treatment is called psychedelic therapeutics, and it combines different drugs and treatments. Awakn is a biotechnology company that conducts research, develops new therapeutics, and distributes existing ones.

Numinus Wellness takes a comprehensive, integrative, and holistic approach to health care, combining the most recent developments in psychedelic medicine with the most effective evidence-based practices. The compassionate access trials for MDMA and psilocybin are being conducted in Canada with Numinus' participation. There are a number of other public and private companies that are manufacturing psychedelics, conducting research on drugs, and discovering new drugs. Every other psychedelic substance, with the exception of MDMA, is either in the preclinical development stage, phase 1 trials, or phase 2 trials.

Academic Facilities for the Study of Psychedelics

The year 2019 marked the official opening of the world's first academic research center that is solely dedicated to studying psychedelics. Soon after that, a multitude of other universities made announcements regarding new centers. The following is a current list of academic initiatives that are focused on psychedelics:

Research conducted at the Centre for Psychedelic Research at Imperial College in London

The Center for Psychedelics and Consciousness Research at Johns Hopkins University

Neuroscape was developed at the University of California, San Francisco.

The Center for Psychedelic Research and Therapy is located at the University of Texas at Austin's Dell Medical School.

Center for the Neuroscience of Psychedelics, located at the Massachusetts General Hospital

The Berkeley Center for the Science of Psychedelics is located at the University of California, Berkeley.

The Center for Psychedelic Medicine is located within the Grossman School of Medicine at New York University.

The Transdisciplinary Center for Research in Psychoactive Substances at the University of Wisconsin in Madison

The Center for Psychedelic Psychotherapy and Trauma Research is housed within the Icahn School of Medicine at Mount Sinai.

Participate in Clinical Trials

If you are interested in participating in a clinical trial involving psychedelics, you should get in touch with a study site in your area. On clinicaltrials.gov, you will be able to find contact information. record kept by the government or by going to the website of the sponsor. The research website will typically have a brief online screening form that you can fill out to see if you have a chance of qualifying for the study.

Following that, a member of the research team will conduct a phone interview with you and may invite you to an in-person screening visit for additional evaluation to determine whether or not you meet the inclusion/exclusion criteria of the trial. Make sure you understand the requirements for participation, and don't be afraid to ask questions.  

This post, which was initially published in July 2018, has been updated to reflect recent developments in the field as they have occurred.