After 24 years… and over 1,200 trials… across more than 75 therapies… Segal Trials is pushing into a new area of expertise—and helping pave the way for psychedelic clinical research.
The company was recently selected as the first research site to conduct MMED008—a Phase 2 study sponsored by MindMed—to test the efficacy and safety of LSD as a treatment for generalized anxiety disorder.
This comes after completing participation—as one of the most active clinical sites—in a Phase 2 study of psilocybin to treat major depressive disorder.
Other upcoming studies include psilocybin and 5-MeO-DMT as therapies for treatment-resistant depression… and psilocybin for the treatment of alcohol use disorder, nicotine use disorder… and obsessive-compulsive disorder.
Researching psychedelics for treating a variety of disorders isn’t a new concept… Throughout the 1950s and 1960s, thousands of such studies were conducted.
But in the wake of the “War on Drugs” and tighter regulations around clinical testing, that research went into almost total dormancy.
However, by the mid-1990s, a slow trickle of psychedelic clinical research began again… Since then, that trickle has grown into a wave—and now a tsunami.
“The research so far has been stunningly impressive in terms of demonstrating the safety and efficacy of psychedelic treatments,” said Dr. Scott Fisher, lead facilitator and trainer for Segal’s Center For Psychedelic Research.
What psychedelic clinical studies entail
Almost all trials use Set-And-Setting (SAS) Protocols, which include preparation, dosing, and integration phases.
The trial participants begin their treatment by undergoing hours of preparation with two experienced psychedelic therapists. The preparation serves to build rapport between trial participants and therapists, thought to be a crucial ingredient to successful psychedelic treatment.
The preparation session(s) also teach the trial participants about the psychedelic drug they’ll be administered… how to build an intention for their treatment… and grounding, mindfulness, and relaxation techniques that could be useful during their dosing session(s).
Treatments are delivered onsite in rooms designed to feel like comfortable living rooms. Trial participants normally wear eyeshades and headphones that play relaxing music.
So far, the trials have examined single or few doses of a very large amount—colloquially known as “heroic” doses because of the extraordinary changes in states of consciousness they typically create. These profoundly altered states are one of the main reasons two experienced therapists are present throughout the dosing process, ensuring the participant’s safety and offering psychological support when needed.
The third phase of treatment is the integration phase, wherein trial participants are asked to reflect on the psychological experience of their dosing sessions. Such reflections often instigate new insights, emotional breakthroughs, spiritual awakenings, and motivation. The support of experienced therapists is often crucial in navigating this complex terrain.
The promising results of modern psychedelic research
So why the recent push into researching psychedelic therapies? Simple:
“New mental health treatments are sorely needed,” said Dr. Fisher. “Our country faces an epidemic of mental health problems, including depression, anxiety, and substance use disorders, for which psychedelics have shown tremendous promise as treatments.”
- In a recent study of MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD), 2/3 of treated patients no longer met the criteria for PTSD after only three MDMA treatment sessions.
- Two 2016 studies of psilocybin for treating anxiety and distress associated with life-threatening illnesses indicated it’s a very promising treatment.
- Small studies of psilocybin for the treatment of alcohol use disorder and smoking cessation showed extremely high efficacy rates.
- Some research has shown that psychedelics can quiet the Default Mode Network (DMN)—the part of the brain that is active whenever we are daydreaming, ruminating about the past, or anticipating the future—in short, when our normal sense of self or ego is operating. Aside from taking large doses of psychedelics, the DMN also goes quiet when we are engaged in task-positive activities, such as playing the piano, concentrating at work, meditating, or being absorbed in a conversation.
But despite such strong results, the FDA requires a high level of scrutiny before allowing any given drug to be put on the market… To get a new drug approved for clinical use, the drug sponsor must complete two Phase 3 studies proving efficacy and safety. The cost of three phases of clinical research usually runs into the hundreds of millions of dollars for a single drug.
As such, it’s essential that drug sponsors have access to the expertise around psychopharmacology, pharmacokinetics, safety, and best practices for psychedelic therapies.
And Segal is one of the few clinical testing sites throughout the country with this expertise…
An impressive team of psychedelic experts
President and cofounder Bonnie Segal and Dr. Rishi Kakar, M.D., chief scientific officer, medical director, and principal investigator, spearheaded Segal’s move into the psychedelic space after seeing its tremendous potential for the treatment of a variety of disorders.
Dr. Kakar was one of the highest enrollers in our Phase 2 study of psilocybin to treat major depressive disorder. He has also been a top enroller in several large-scale clinical trials around bipolar disorder, schizophrenia, major depressive disorders, and opioid use disorder.
Dr. Fisher is a psychiatrist certified in psychedelic therapy from the California Institute of Integral Studies. His background includes training in classical psychedelics, such as LSD, psilocybin, and DMT. And he’s been certified in MDMA-assisted psychotherapy for treating PTSD by the Multidisciplinary Association for Psychedelic Studies. Dr. Fisher has built a team of therapists with an interest and expertise in psychedelic treatments, and is developing an in-house psychedelic therapy training program. He also helps psychedelic drug sponsors by advising on their protocols and therapy manuals.
Segal’s team has 70 years of collective clinical trial experience… dedicated recruitment, marketing, retention, and community outreach teams… several partnerships with mental health support groups, a private transportation service… and a collaborative referral network with the largest psychiatric clinic in South Florida.
Segal has also received several awards for enrolling patients quickly and breaking the stigma surrounding clinical research. This dedication has resulted in 56 FDA-approved medications, largely for mental health conditions.
What’s next on the horizon for Segal’s psychedelic research?
To date, the only completed Phase 3 study in the psychedelic space has been the study mentioned above around MDMA for the treatment of PTSD.
In other words, there is still a lot of work left to do.
Segal continues to actively meet with sponsors of psychedelic drug trials, with the aim of significantly growing the Center for Psychedelic Research over the next couple of years. To achieve that—and accommodate growing demand, it plans to relocate to a much larger center within the next 6–12 months. The new site will allow Segal to conduct Phase 1 trials in addition to Phases 2 and 3.
The bottom line: This is just the beginning for Segal’s psychedelic research.