Clinical Trials in Psychedelic Therapy: the good news (and the possible bad news)

Clinical trials are the pathway of research that pharmaceutical companies take as they work to explore the risks and benefits of any new therapy. There are thousands of clinical trials that are ongoing in the world, and some of these trials are currently evaluating new psychedelic medicines.  Clinical trials are an important step that all new medicines must take in order to reach the market, and in order to become prescribable by physicians.  The purpose of a clinical trial is partly to test a new medicine, and to see how well it works to treat an illness.  Some clinical trials aim at determining the best dose of a medicine, or to see which illnesses respond best to the medicine.  Other clinical trials are created to compare a new treatment to old or existing treatments. All clinical trials are careful experiments that test a new medicine (or even an old medicine that is being used in a new way).  The government website  for clinical trials https://clinicaltrials.gov/ lists all currently active clinical trials.

What are the potential Benefits?

What possible good news does participating in such a scientific experiment hold for the average patient?  Well, there are several possible benefits.  The first benefit is access: a clinical trial gives patients access to medicines that are not yet approved, and these are  drugs that are not yet available for use.  In the case of psychedelic medicines there are several (e.g. LSD, MDMA, psilocybin) that have been identified by the FDA as  “breakthrough” therapies.  This means that the preliminary testing has shown unusual promise in human beings, and the drug research is expedited when a drug reaches this status.  By enrolling in a clinical trial, a patient can gain access to a new medicine that has not reached the market yet.  Enrolling in a clinical trial can also help advance science, and move new medicines forward, benefiting all of us.

What other benefits might be possible by enrolling in a clinical trial?  Well, frequently, (but not always) the cost is free for treatment on a clinical trial.  Some trials even will pay patients, particularly if the possible benefit of the trial to the patient is less certain. I also think that another benefit of being on a clinical trial is the careful attention that is paid to those who enroll.  Even more than in regular medical practice, every detail of your care, your lab results, your symptoms, and any side effects are examined and carefully noted.  I think that, in general, individuals who enroll in a clinical trial receive extra attentive care from their nurses and doctors.

A welcoming therapy space designed for comfort and healing

What is the possible 'bad news' about clinical trials?

What kind of ‘bad news’ is possible about being on a clinical trial?  Well, there might be a few things.  Clinical trials are careful experiments and good science requires lots of rules.  Sometimes the attention to the rules, and the extra testing can be inconvenient to the patient, or even difficult. It is a price that everyone pays, both as caregivers and as patients.  One bright side is that all clinical trials themselves must pass the scrutiny of a special committee (The Institutional Review Board or IRB), made of clinicians and lay people.  This board looks at every clinical trial rule from the patient’s point of view.  They carefully examine the ethics and fairness of the trial, and the legitimacy of the questions that are being asked by the trial. Besides the rules of the trial, another possible drawback might be the side effects of the medicine. A summary describing risks for the experimental medicine are detailed in the ‘informed consent’ (IFC) document that is signed by the patient and the doctor before enrollment.  This document lists possible side effects and possible reactions to any new medicine.  The IFC is an attempt to honestly describe the risks of a clinical trial, and special care is taken to support individuals who enroll.

Therapist and patient engaging in reflective journaling during therapy

The Clinical Trial System, and the future

As a physician, I have had the honor of being a part of (and of leading) many clinical trials over the years.  I have to say that I still believe in the clinical trial system, and I think that human research is something that truly guides my understanding and helps my care for patients and clients with better insight.  My colleague, Jenna Witkowski and I are honored to be members of the Psychedelic Science Initiative at Roswell Park Cancer Institute. In this role, we both look forward to participating in new clinical trials for psychedelic therapy.  One of these trials, called "the Rekindle Trial" (sponsored by the pharmaceutical company, Reunion) is expected to open at Roswell soon. https://www.rekindlestudies.com/. Stay tuned!