How psychedelic clinical trials are being affected by coronavirus Almost all clinical psychedelic drug research is being affected in some way or another by COVID-19. But, response measures vary from one organization to the next. | In In Magazine | By By Russell Hausfeld

The COVID-19 outbreak is affecting many clinical drug trials. Pfizer has paused enrollment in most new and ongoing clinical trials for at least the next three weeks, with the exception of enrollments for trials that may aid life-threatening conditions. Eli Lilly, Galapagos, Gilead Sciences, and many others have taken similar actions. Organizations conducting clinical trials on psychedelic drugs are taking precautions for the safety of patients and researchers, as well.

The Multidisciplinary Association for Psychedelic Studies (MAPS)—which is conducting a multi-site Phase-3 study of MDMA-assisted psychotherapy for PTSD—is postponing enrollment and making use of technology-based options for patient follow-up.

“In the setting of the COVID-19 pandemic, the safety of our study staff and participants is of paramount importance. All of our clinical trials enrolling healthy volunteer participants are postponed to minimize risk of exposure and to adhere to social distancing. For our clinical trials treating participants with PTSD, the risks and benefits of ongoing participation for the current participants and study staff are constantly being weighed and determined largely on a case-by-case basis. All visits that can be conducted remotely are being done using teleconferencing. At this time, [March 27], about half of the study sites are continuing with in-person day-long experimental sessions with MDMA or placebo, although this number is likely to decrease as the risk of exposure and public health interventions increase. New enrollment of participants is on hold, and focus is being shifted to clinical trial protocols which can be done entirely by virtual visits,” said Alia Lilienstein, MD, MPH, the Medical Director of MAPS Public Benefit Corporation. I checked back in on April 6, and protocols remained the same.

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COMPASS Pathways—which is conducting the largest-ever trial using psilocybin to aid treatment-resistant depression—stated in a newsletter that they have paused the inclusion of new patients in clinical trials. Their contracts with clinical trial sites will continue despite the pandemic.

“Patients who have already joined our study will be supported remotely, when possible within the [FDA] protocol,” the newsletter reads. “We believe this is the right thing to do as it reduces risk to patients and clinical teams, and supports the measures for social distancing being introduced around the world.”

COMPASS Pathways will also continue pre-screening where possible, in order to resume enrollment quickly when it is deemed safe to do so.

MindMed—a psychedelic pharmaceutical company which recently went public—took a different approach, announcing March 25 that they have begun enrollment in human safety studies of 18-MC, the company’s iboga-derived drug for the treatment of opioid use disorders. MindMed claims their team is closely monitoring COVID-19 and “taking the necessary precautions to protect the health and safety of patients and staff.”

“Due to the global nature of drug development, we have built our company to function in a geographically distributed manner every day on Zoom. Because of this decision our work has continued uninterrupted and will pay dividends to our efficiency in the months ahead,” said MindMed’s CEO JR Rahn.

MindMed’s release goes on to state (somewhat tastelessly) that the company “anticipates that the COVID-19 pandemic will only increase demand for MindMed’s innovative medicines and disruptive technologies to address unmet needs in mental health and addiction resulting from the crisis.”

The Beckley Foundation—which is involved in a clinical trial using psilocybin for smoking cessation—has made no public comments on their clinical trial work, but posted on Facebook that the organization “will continue to work and use this time to evaluate how our priorities can align with the shift in societal needs. This crisis is rather unique in that we are all facing the same shadow, and this represents a unique opportunity for us to grow together and overcome these challenges as a global community.”

Johns Hopkins Psychedelic Research Center—which is conducting clinical trials using psilocybin for anorexia nervosa, Alzheimer’s disease, major depressive disorder, and more—stated on Twitter that the research team has paused all study visits due to COVID-19, but has not stopped recruiting for studies. Johns Hopkins University released a statement that university meetings and work activities, even those deemed essential, must be conducted remotely whenever possible. And, no in-person activities may be held with more than 10 people, except for select types of clinical care. As of March 18, all of Johns Hopkins’ on-campus research was restricted to essential activities only. Lab work specifically related to COVID-19, however, will expand and continue.

The Center for Psychedelic Research at Imperial College—which is involved with clinical trials using MDMA for alcoholism, and psilocybin for major depressive disorder—has not made any public statements regarding COVID-19. However, the Imperial College of London released a statement saying that “only essential research and operational activity is now taking place on our South Kensington, White City and Silwood Park Campuses. Building access will only be granted in exceptional cases.” It is not clear whether psychedelic clinical research is deemed essential by the university.

It is possible that clinical trials outside of those treating life-threatening issues will be disrupted for months to come throughout most of the world. Only time will tell how this pandemic will affect psychedelic clinical trial research in the long term.