photo courtesy Samuel Zeller
Are you interested in joining a clinical research trial for psilocybin? Psilocybin is under investigation for treatment-resistant depression, major depressive disorder, anxiety associated with life-threatening illnesses, obsessive compulsive disorder, anorexia, alcohol and nicotine dependence. Studies are also enrolling healthy volunteers. Here are five things to know about what to expect and how to get involved in psilocybin research studies.
1. How can I find psilocybin clinical trials?
All clinical trials in the United States testing a drug product or medical device in humans must register at clinicaltrials.gov. Each trial record provides a summary and detailed description of the study. Here you will find information about the interventions being tested, the outcome measures, and eligibility criteria. Importantly, the record lists the trial locations and contact information for the study sites. Many other countries have similar trial registries.
To help you find trials, we have compiled a comprehensive list of psychedelic clinical trials that we update regularly. Click here to view the list.
2. Am I eligible to participate in a trial?
Each trial has very specific criteria for enrollment. A participant must meet all inclusion and exclusion criteria to be eligible. The inclusion criteria will specify what type of health condition the trial is investigating or if the trial is enrolling healthy volunteers. The exclusion criteria lists conditions people can’t have, generally because they may pose greater or unknown safety risks for ingestion of the investigational product.
You can review the criteria in the clinicaltrials.gov trial record, but oftentimes some criteria are not listed publicly in the record because the trial sponsor does not want participants to be untruthful when applying. For example, a trial may have a lifetime limit for the number of psilocybin doses a person has taken in the past or the trial may be seeking psychedelic-naive participants. Just because you meet all the criteria listed in the record doesn’t mean you will meet the full inclusion/exclusion criteria of the trial sponsor.
If you do meet the criteria listed and live nearby a study site, the next step will be to contact the study site listed in the record. Try both the email and phone contacts. Many people are seeking out psychedelic clinical trials so persistence may pay off here. After you reach the study staff, you will undergo a phone screening. If you potentially qualify after the phone screen, they will invite you to the study site for a rigorous in-person screening process to assess your psychological and physiological functioning. If you qualify for the study, you will be informed about the study design, potential risks, compensation, schedule, and so on. You must give your informed consent before starting a study and know that you can withdraw at any time for any reason.
Example Inclusion / Exclusion Criteria for a Trial
|Inclusion Criteria||Exclusion Criteria|
|21 to 65 years old||Pregnant and nursing women|
|Moderate to severe depression||Cardiovascular disease|
|Depressive episode for at least 60 days||Epilepsy|
|Have a support person||Schizophrenia or psychotic disorder|
3. Who is sponsoring psilocybin clinical trials?
Clinical research can broadly be broken down into trials that are 1) investigating drugs to evaluate safety and efficacy for treating health conditions with the goal of becoming FDA-approved medications, or 2) academic studies aimed to provide information about mechanisms of action, clinical applications, repurposing of already approved medications, etc. but are not structured to gain regulatory approval.
Pharmaceutical companies sponsor drug development trials but there is one nonprofit organization, the Usona Institute, that is conducting psilocybin trials to gain marketing approval from the FDA. The drug sponsor contracts with independent study sites to carry out the study procedures and data collection. Universities can be study sites, as can clinics and hospitals. Academic studies aimed to broaden scientific knowledge are typically funded by government grants, foundations, or through private and public donations.
Psilocybin research is currently being conducted by pharmaceutical companies and by academics at Universities. When considering a trial to enroll in, it’s a good idea to become familiar with who is sponsoring the trial, what the data will be used for, and how your values align with the goals of the sponsors or researchers.
Psilocybin Drug Sponsors and Academic Institutions (United States)*
4. What should I expect if I’m enrolled as a participant?
The study designs vary greatly between trials. Some studies have many in-person visits, including all-day sessions and overnight stays. Other studies have a less intensive schedule of visits. Give some hard consideration to the time requirements and burdens that come with study participation, like having to miss days of work or arranging child care. Do you have the resources and time to commit to completing the trial?
Blinded trials will administer psilocybin and a placebo control. Participants are randomly assigned to either treatment group which means you have a good chance of receiving the placebo. Many people are extremely disappointed when they realize they didn’t receive the psilocybin dose. Some even withdraw from the study which can be very problematic for data analyses. If you can’t live with the fact that you may have to complete the study while receiving the placebo then it’s best not to enroll.
Most psilocybin trials require participants to not be on specific medications that may interfere with the effects of psilocybin (serotonergic drugs) or confound the data collection for the indication understudy. Some studies will let people enroll and then taper off excluded medications. Discontinuing psychiatric medications is difficult for many people. Symptom severity can increase and other side effects occur. Weigh your situation carefully, ideally with your doctor, to figure out if discontinuing medications is something you could feasibly do if enrolled. Do not discontinue before discussing with the study team as you may end up not being enrolled for other reasons.
5. How will I benefit from joining a psychedelic clinical trial?
Clinical trials do not guarantee any benefits to you. Most will offer compensation for your time and supportive care from the study team, but since the treatment is investigational and a placebo dose is a possibility, you can’t count on it being an effective treatment for you. If you do find yourself lucky enough to be in the psilocybin group, then you will have access to this treatment before it is widely available. But whether you receive psilocybin or placebo, you will contribute to leading-edge research that could pave the way for millions of people suffering from mental health disorders to get this treatment in the future.