Beyond the Hype: Addressing Safety Challenges in Psychedelic Trials

Psychedelic Clinical Trials, CNS

Emerging evidence showing therapeutic benefit of psychedelics for mental illnesses such as major depressive disorder, substance use disorder, and post-traumatic stress disorder, has captured the interest of clinical researchers, the general public, and Netflix-watchers. Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that accompany psychedelic-assisted therapy treatment models.

Patients participating in any psychiatric trial have a degree of vulnerability due to their illness. In psychedelic research, this vulnerability is amplified when patients receive consciousness-altering drugs, even in a highly controlled setting.

Session Safety Measures

Setting agreed-upon boundaries between therapists and patients helps protect all individuals. For example, it’s possible a psychedelic session could become difficult for a patient and if agreed to, physical touch or other interventions to calm the patient may help. Therapists need training to deliver these interventions in a way that keeps the patient and themselves safe while maintaining integrity of the study. An appropriate psychedelic-assisted psychotherapy protocol should account for safety measures and may include things like ensuring a dyad of trained therapists are in the room throughout the dosing session and those sessions are videotaped and actively monitored. Sites should also be carefully selected for their ability to safely execute your protocol and have appropriate follow-up measures in place in the event symptoms worsen.

Patient Selection & Consent

It’s also important to consider where a patient is in their mental health treatment journey. Some patients interested in participating may have tried many options without sufficient treatment response. It’s possible your psychedelic trial is their perceived “last hope,” which may influence or bias data on their response (or lack thereof) to treatment.

This patient sentiment is not uncommon in clinical research. Many cancer patients or patients with neurodegenerative disorders may place similar hope in a clinical trial. But in a psychedelic trial that includes a control group, patients are likely to correctly guess their treatment assignment given the mind-altering effects of psychedelics. Coupled with an intense hope for treatment benefit, patients can experience a worsening of symptoms when realizing they are on placebo. It is also possible that patients taking active treatment have a difficult psychedelic journey and subsequent worsening of symptoms.

For this reason, it’s important to carefully select the right patients and therapists and have an appropriate safety plan in place. For the patients you do select, setting clear expectations is necessary through a detailed informed consent process and preparation for study participation so patients (and their families or caregivers) fully understand what could happen. Patients must also understand participating in a clinical trial is an investigation, and there is no certainty of receiving therapeutic benefit even if they receive the active drug. Patients and sites should be thoroughly trained to manage patient expectations and maintain the integrity of the study. For more information on how to manage patient selection and site training, check out our recent webinar.

Post-Study Care Continuity

These studies often involve considerable time with individualized therapy and development of treatment bonds between patient and therapist. Care should not abruptly end when the study is over–consider how to maintain care continuity when your study ends. If continuing the psychedelic-assisted psychotherapy is possible, this should be supported. But when it is not possible, your protocol should include other ways to support patients, whether through continued psychotherapy or referral and follow-up elsewhere.

To one day see how psychedelics may change the mental health treatment landscape, we must make sure to keep trial participants and site staff safe, supported, and protected. Despite being a relatively new area of clinical research, we have a team of experts who have supported a number of psychedelic researchers with advancing their compound into trials. Our Christine Moore, PhD, Vice President of Scientific Solutions, Neuroscience, recently covered a few considerations for designing psychedelic protocols with BioPharma Dive. You can also learn more from our psychedelics team about operational considerations for trials in our recent webinar “Demystifying Complex Operations in Psychedelic Research“, or you can contact us directly to discuss your program.

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