Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “Demystifying Complex Operations in Psychedelic Research,” available on-demand now.
If you missed it, you can watch the full webinar and read a high-level recap of what we covered:
1. Psychedelic trials need to be done with scientific rigor.
Even though some natural psychedelics have been used for a long time and current data suggest a favorable safety profile, there is still much to be known and understood about efficacy and their safety profile in different populations. As we look to study psychedelic compounds in larger and more generalized populations, we need to execute these studies with rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials. You can find their full article, here.
2. Sites bear a lot of responsibility and need to be carefully selected.
In any clinical trial, a portion of the success or failure of the trial can be attributed to the site selection strategy and site participation, and this holds true even more for a psychedelic trial. That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities. They require trained raters and therapists, technology to record sessions, and methods in place to help protect the blind. Conducting thorough feasibility data when selecting sites is paramount. Worldwide has created this handy checklist to help you select sites for your study.
3. Therapists play an integral part in the patient’s experience.
Unlike most trials which try to minimize nonspecific therapeutic effects on study outcomes, many psychedelic trials incorporate psychotherapy. Trained therapists help a patient work through their experience physically, emotionally, and spiritually for up to several hours. It’s not uncommon during a session for a patient’s trauma to surface or for the patient to have a psychologically complex experience, requiring the therapist to help them work through it and process the emotions, thoughts, and memories that arise. As previously mentioned, therapists need extensive training to execute the therapy well, and patients need to understand the role of a therapist, as they can influence the direction of the patient’s experience.
4. Raters and therapists are not the same.
Therapists are responsible for delivering psychotherapy or support to a patient as they undergo their dosing sessions; raters are responsible for collecting unbiased outcome data on the impact of the psychedelic. In order to protect the study’s data and shepherd the patient through their experience, these are two distinctly different roles which cannot overlap or interact. Raters need to maintain their independence from other study procedures. Utilizing a third party to ensure they are separate can be helpful. Training the raters on their specific role in the study in addition to training on the proper administration of outcomes measures will help to maintain independence.
5. Patients and site staff face safety concerns.
Your patients will be in a consciousness-altering state during dosing sessions in addition to their baseline vulnerability from the impact of their illness. This creates a potential safety concern for these patients, the site staff, and the therapist who is conducting the sessions and responsible for protecting the patient. All parties need to be thoroughly informed about what to expect and agreed-upon boundaries should be set in case the session becomes challenging. If patients provide consent, the session should ideally be videotaped and reviewed or observed live by a third party.
Beyond the actual study sessions, patients should have regular check-ins, be closely monitored for suicidal symptoms, and safety alerts should be in place. More guidance on safety considerations can be found, here.
6. Certain licensing must be obtained.
Since psychedelics are usually Schedule I drugs, prescribing and transporting them for a clinical trial requires obtaining certain licensing. Depending on the country (and in the US, the state), licensing can take up to a year to secure, which can greatly delay timelines. Additionally, licensing is also continuously evolving, making it necessary to stay abreast of the latest changes.
Our panelists shared even more operational insights in the webinar, such as why a screen fail rate over 50% is normal and how to reduce your rate; how to select patients for your trial and design a recruitment strategy; and more details on what we covered above. Check out the full webinar!