Accel Research Sites

As we look toward the New Year, those of us in the clinical trial field are thinking about the next big thing. In 2023, what breakthroughs will we see? What areas will excite us?

For us at Accel Research Sites, one area we see as innovative and novel is actually a field that is centuries old. Psychedelic medications have been used in various forms for many years, with roots in Native American and Eastern medicines.

According to Accel Research Sites Chief Principal Investigator Dr. Marshall L. Nash, when many people think of psychedelic medication, they think of mushrooms—psilocybin. The field is actually wider and includes more mainstream drugs, such as the much-studied ketamine.

Earlier in the 20th century, Dr. Nash said, medical professionals and researchers were fascinated by the possibilities psychedelics held. In fact, studies in the 1960s and ’70s showed improvements for patients with PTSD, major depression and generalized anxiety disorder, even with just a single dose.

The War on Drugs and tightening of controls in the pharmaceutical industry, however, closed the door on many of the promising studies that involved psychedelic medication, Dr. Nash said.

Now, that door is open once again, and Dr. Nash said the possibilities are exciting.

“We want to see if the knowledge we have from previous studies is correct,” Dr. Nash said. “We’re just picking up where the research left off.”

That’s possible for a few reasons, Dr. Nash said. One is that researchers have seen success in other areas of the field, such as with ketamine. In fact, Dr. Nash said, ketamine is the standard of care now for some physicians.

Seeing success in the gene therapy field is another reason those in pharmaceuticals are taking another look, he said. Here, the field has progressed to see amazing results with single-dose treatments. The immense promise of such results with just one treatment is opening people’s minds to the possibilities of curing diseases thought to be chronic, building off previous psilocybin research.

The situation, Dr. Nash said, is similar to work with stem cells, which was put on hold in the late ’80s and ’90s but has come back into the mainstream.

At Accel, Dr. Nash said, the interest in the psychedelic field is on improving the quality of life for patients. He sees possibilities with the indications above, but also for age-related depression, anxiety and trauma.

The company is uniquely poised to delve into the field, too, Dr. Nash said. Psychiatric research has always been one of Accel’s core competencies, and several of the company’s primary investigators have significant psychiatry experience, including Dr. Jorel Martinez, Dr. Rosario B. Hidalgo, Dr. Rosa Negron Munoz, Dr. Andrea Marraffino, and Dr. James Andersen. Several of the company’s locations, including Lakeland, Florida and Maitland, Florida, also have expertise with long-term psychiatry trials and the ability to set up classroom studies for even more possibilities, such as with ADHD. Accel’s focus on patient health and well-being also fits well with the missions of many of the pharmaceutical companies who are passionate about this field of drug development.

Dr. Nash said he and Senior Director of Business Development and Outreach Karen Kolin recently attended the CNS Summit, where psychedelics, particularly study design and the future of the field, was a hot topic for sites and sponsors alike.

He said the field now is experiencing a Rip Van Winkle effect. It’s rising from a 30- or 40-year slumber, and those involved are looking forward to what’s next with Phase II and Phase III studies that build off what’s known.

“It’s like they say in Star Trek,” he said. “We’re boldly going where no man has gone before.”