Changing perceptions of psychedelics with clinical trials

Founded in 1998 to offer scientific and regulatory support services, NST has grown over the past 25 years, expanding its service offering to include various aspects of clinical study management. Emphasizing long-term relationships and prioritizing quality over profit, the company’s clientele consists of blue-chip pharma, biotechs, and competitor/partner CROs as well as academic research groups.  

“We work with clients who are looking for tailored solutions to their specific problems, delivered by an established, small and flexible team who they know and trust: for example, biotechs or start-ups facing resource challenges where our team’s know-how can be rapidly deployed to their best advantage,” explains Tim Hardman, Managing Director. 

Embracing the unknown

NST has worked with a broad spectrum of psychedelics, including N, N-Dimethyltryptamine, ibogaine, and psilocybin. Drug candidates for investigation are often derived from natural sources, perhaps having been used historically in shamanic rituals. The company is hopeful of the potential psychedelics may offer in addressing unmet medical needs, providing alternate treatment options for patients who have exhausted existing treatments and therapies. 

Overcoming hurdles

The current fascination within the popular media surrounding psychedelics presents both opportunities and challenges. While the growing interest in these substances has opened new avenues for research and development, it has not served to address deep rooted concerns over the potential recreational use of psychedelics, the conservative opinions of the general population or to lower regulatory hurdles. Despite the long history of their use, the industry recognizes the need for rigorous scientific studies to validate their safety and efficacy. 

In conducting clinical trials and working closely with sponsors, NST aims to navigate the regulatory landscape and contribute to the growing body of evidence supporting the therapeutic potential of psychedelics. 

The role of psychotherapy

One distinctive aspect of psychedelic trials is the integration of new therapeutic modalities with existing beneficial approaches, such as psychotherapy and cognitive behavioral therapy. The goal is to combine the therapeutic effects of the substances with supportive psychological interventions to maximize the benefits for patients. How best to achieve this has still to be determined. 

By providing a controlled and structured environment, the trials aim to help researchers process the experiences of study participants to determine how best to achieve positive outcomes. This consideration highlights the importance of a comprehensive treatment model that goes beyond the administration of drugs alone. It is also important to remember that in the case of mental health it is rare that one size or solution fits all. 

Exploring novel approaches

One intriguing avenue within the field of psychedelics is the search for compounds that offer the potential to deliver targeted psychological benefits without inducing the extreme sensations or hallucinations commonly associated with psychedelics, figuratively described as trips.

Researchers are investigating molecular variants of known psychedelics that have the potential to maintain mood-altering effects but eliminate subjective experiences. This approach aims to leverage the plasticity of the brain in the absence of the unpredictability of psychedelic experiences, potentially broadening the applicability of psychedelic therapy. Whether this angle represents an actual therapeutic benefit or whether it simply addresses the conservative stigma associated with the use of psychedelics remains to be seen. 

“When a sponsor develops a drug that’s based on a natural compound, they usually have their own specific variants thereof,” says Dr Hardman. “For example, they will be looking to try and get a better pharmacodynamic profile with fewer trip-like side effects. It raises interesting sociological questions around the targeting of psychedelic-based products without the so-called trips and whether this aspect is essential to achieve their full therapeutic potential (and whether this is even possible). These trials are not about exploring new drugs. They are navigating towards therapeutic solutions based on pharmacology AND psychotherapy. It all must be investigated under controlled circumstances.” 

The future of research into psychedelics 

The team at NST envisions a future where psychedelic-based drugs are recognized as valuable treatment options, provided they meet stringent safety and efficacy standards. To achieve this, extensive research is required, involving multiple studies for each substance that will require collaborations with clinicians as well as various pharmaceutical and biotech companies. 

Utilizing Viedoc for collaborative clinical trials 

The flexibility and customization options offered by the Viedoc eClinical suite have been instrumental in accommodating the unique study designs that NST uses. 
 
“Trial sponsors often come to us with novel study proposals,” adds Dr Hardman. “Depending on the service we are providing, we may be helping them write their Investigator's Brochure and Investigational Medicinal Product Dossier, we may be helping them develop the protocol, and then it is working with them on delivering the study, whether that be setting up and servicing the electronic Trial Master File or conduct the study monitoring. We can coordinate many of our activities using Viedoc products.”

By enabling project managers to program the system themselves, Viedoc empowers the study team to adapt and tailor the platform to their needs. This level of flexibility saves time and enhances efficiency.

“I wouldn’t say that all project managers are control freaks, but a fair number are,” says Dr Hardman. “And I have worked with a lot of eCRF designers who have been great at understanding their technology but struggle with interpreting the protocol, incorporating it with the CRF because they are not familiar with protocols or the science behind it. 

We love the flexibility that Viedoc offers us. We work with some unusual study designs, and we appreciate the fact that we can program it ourselves—and the fact that with some straightforward training non-programmers can become eCFR designers.”