Planning a Better Trip in Psychedelics Research
August 15, 2023
Psychedelics are big business for the drug market, with an estimated 2029 valuation of $11.82 billion USD (compared to $4.87 billion in 2022). While this rapid growth is indicative of the excitement surrounding positive study results for the treatment of PTSD, treatment-resistant depression and other conditions, these therapies pose numerous challenges throughout the clinical trial process. With the right-fit partner, though, solutions flex to the needs of your unique psychedelics trial, taking into account both standard best practices and the specific difficulties with trials of this type.
A wide range of substances fall under the psychedelics umbrella, but for the purposes of this discussion, the term refers to what the FDA calls “classic psychedelics,” including psilocybin, LSD and MDMA, encompassing drugs that “act on the brain’s serotonin system, as well as ‘entactogens’ or ‘empathogens.’” Given the release of this organization’s recent draft guidance on psychedelic clinical trials, our goal here is to break down the difficulties inherent in researching these therapies and provide insight on how the right partner can help ensure they’re effectively addressed without delaying results or adding risk to the process.
Choose the Right Place With the Right People
While finding the right site and staff for any clinical trial can be challenging, the added requirements of psychedelics research greatly expand the level of difficulty. The Schedule I status of most drugs included in these studies means that you’re obligated to follow processes outlined by both the FDA and the DEA. For the latter, this requires site registration with the DEA to handle these drugs in a research capacity. To make sure you find a quality location cleared for psychedelic research, you need a partner with a robust network of trusted sites who understands your specific needs. It’s not enough to just get a site with the authority to work with Schedule I substances; you also need a site that fits every part of your research. Ensure you work with a partner who discusses your research parameters and needs in detail with you, dedicating themselves to determining which site meets your specific trial needs, those of the DEA and any state-level requirements (such as controlled dangerous substance (CD) certification).
Beyond site-level registration, there are also registration requirements for any research staff who will be handling Schedule I substances. Compounding possible issues for your trial, these requirements are in addition to recent FDA guidance calling for two monitors for the duration of a patient’s treatment session (which could last for hours), including a lead with adequate professional credentials and licensing and an assistant who is a college graduate with at least a year of experience. Together, these specifications call for a sizeable team to handle long treatment duration but place somewhat strict limitations on who can be admitted to that team.
Finding the right team for your clinical trial starts with a collaborative CRO partner that has existing relationships covering a large network of research professionals. Because your team is chosen specifically for your trial from a curated list of eligible talent, you have a faster track to experts who meet the unique needs of your research and can satisfy regulatory requirements. Coupled with the site location benefits you receive from an organization with an extensive pre-screened database, the right CRO can ensure a smoother trial experience for sponsors and patients alike.
Develop a Sound Strategy
The design of your study raises even greater challenges for your psychedelics research. Among the host of issues impacting this area are the challenges of finding an appropriate patient population, outcome reporting and placebo inadequacy.
Selecting suitable patients for your trial and ensuring an adequate sample size is made more difficult by the subjectivity of diagnosis for conditions like depression, anxiety and other mental health disorders. With classification often based on patient-reported outcomes or behavioral evaluations, confident selection can be difficult. Since your study also needs to take into account any possible interactions with current medications for a target population often already in treatment, there are many aspects that define the right patient. For the success of your research, it is vital you partner with an organization with an established network of patients who can be filtered by applicable attributes. This allows you to meet enrollment goals more quickly with patients who fit the parameters of your trial.
Optimizing Outcome Reporting
With the mental health focus of these trials and the individualistic nature of psychedelic experiences, patient-reported outcome measures are a necessity. Unfortunately, this often takes the form of lengthy questionnaires, which can be a challenge for patients suffering from a mental illness, who may be overly stressed, fatigued or otherwise compromised in their capabilities. CRO collaboration offers the chance to develop patient questionnaires and other self-reporting tools that fit the population with whom you’re working, whether they need a questionnaire that works with their attention span or a different reporting method altogether. A consultative partner tailors these solutions to your study using extensive experience proven to get the best results from patients.
Addressing Placebo Inadequacy
Among the more difficult issues to overcome in psychedelics trials is that of placebos. While traditionally useful for blinding studies, placebos have limitations in a research field that includes drugs that have such profound and direct effects on perception. It is, for instance, fairly clear if someone has been given LSD or a placebo, and this is as true for researchers as for participants, which gets in the way of double-blind study procedures. This issue can easily skew results, as a participant and patient, both keenly aware that the former has received a placebo, may struggle to go through the motions of the counseling elements as though they are working with the study drug. While developments in active placebos meant to trigger similar sensations as psychedelics and high-dose/low-dose attempts at blinding have shown some success, the right CRO can help you develop informed strategies that ensure your results best represent the actual effect of the drug itself.
Adding the CRO Effect
Given its boom in popularity, the psychedelics clinical research environment is quickly evolving, but keeping up with the changes can be daunting. Collaborating with a CRO for site selection, staffing, patient engagement, and study design helps you meet the guidelines, regulations, and considerations for these trials more easily. Look for a partner who has a large, pre-screened site network from which they can pull, an equally robust pool of patients from which to draw and the clinical trial experience to help you determine your best methods for meeting requirements. The right CRO will have experience with specialized research, giving them a head start on dealing with expanded guidelines, and they’ll understand sponsor and patient needs in emerging areas, keeping ramp-up time to a minimum. Psychedelic clinical trials come with multiple layers of special considerations, so be sure you have a partner with the skill set and agility to address them all with foresight and flexibility.
Have a psychedelic clinical trial that needs a hands-on partner? Collaborate with PRC Clinical for right-size, right-fit partnership and solutions that guarantee results.