Newsletter
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This month at Fluence we take a break from our webinar series to rest and regroup before the busy fall season. Many therapists are on vacation or simply have a lighter schedule due to clients' vacations. It's the season to enjoy the long days and time outdoors. But not everything is on pause: Research studies are moving right along and in just the last month we received a number of requests for our research therapist training services, indicating a strong continued commitment to producing the best quality programs and reliable findings to meet the urgent need for improved mental health care.
Clinical research studies in the psychedelics field can be understood in two major categories, academic and drug development, and Fluence works with both kinds. Both kinds of studies involve rigorous planning and approval process, participant protections, and lead to scientific findings that contribute to the body of literature. The major distinction is that academic research studies (sometimes referred to as investigator initiated studies) are not necessarily intended to advance the therapy toward approval by the FDA to be marketed as a treatment, whereas studies that are part of drug development programs have this as part of their conception and intention. The structure and data that are collected may be very similar, but the impetus for conducting each kind of study is essentially distinct.
Academic research is usually funded by government grants or private donors. Historically, the National Institutes of Health provided relatively little grant funding for research into psychedelics as therapeutic treatments. Notable exceptions are research studies on psilocybin for smoking cessation and opioid use disorder. Organizations like Heffter Research Institute have also collected private donations and used them to support academic research trials. These funding sources can support research that may be exploratory or adjacent to the goals of drug development studies. These organizations aren’t looking at the funds as an investment with a potential financial return, rather, they expect results that are meaningful and make a contribution to the scientific literature or otherwise advance knowledge. Sometimes those results are later used to inform drug development studies.
Studies that are conducted as part of drug development programs are funded by organizations with interests in receiving FDA approval to market the treatment for a specific indication (diagnosis). These organizations, referred to as Sponsors, are responsible for funding the research and submitting the appropriate applications to the FDA. Sponsors are typically private or publicly traded companies. Over the last few years several dozen new biotech companies have started sponsoring research with psychedelics. These companies tend to start small and grow as their research gains momentum. As the field grows I expect some of the smaller companies to merge or be acquired by bigger ones with the resources to conduct more extensive programs of research.
So what do therapists need to know about all of this? If you are keeping up with the research it’s good to understand why some studies may have more of an academic focus and others are being conducted primarily to establish whether or not a drug is safe and effective for a particular indication. Two studies of the same drug for the same indication may have different structures and goals because of this. And, sometimes sponsors contract with academic institutions to conduct studies, so just because a study was conducted at a university doesn’t mean it is an academic study as I’ve defined here. Published research should always include disclosure of funding sources.
If you want to work on a research study it’s helpful to think about which kind of study you prefer to be involved with. Academic studies often have smaller budgets and are held at just one or a few sites, while drug development studies may include dozens of sites. It is also helpful to think about what kind of setting you want to work in. Academic research sites usually have more complex onboarding requirements regardless of whether or not the study is investigator initiated or sponsored, but sponsored research happens at a mix of academic and private sites that can be easier for clinicians to work with. Both kinds of studies should provide great professional experience, including funded training and the opportunity to try out experimental therapies you won’t have access to outside of the research environment. Both are important and valuable, and I see them as complementary.
As we create more and more psychedelic research therapist training programs, for both academic and sponsored research studies, I look forward to welcoming many more therapists to the field of psychedelic therapy through these projects.
Thanks for reading,
Fluence Co-Founder
Joseph McCowan PsyD, is a licensed clinical psychologist, working in Los Angeles as a Therapist and Supervisor in the MAPS sponsored Phase 3 clinical trials of MDMA-Assisted Therapy for PTSD. Joseph supports the MAPS MDMA Therapy Training Program as a training assistant, and supported efforts toward increasing the diversity of therapists and participants in the MAPS clinical trials as part of the MAPS Diversity Working Group. Additionally, Joseph practices at the California Center for Psychedelic Therapy where he provides Ketamine-Assisted Therapy and Psychedelic Integration Therapy.
Along with his training in MDMA-Assisted Therapy and Ketamine-Assisted Therapy, Joseph is trained in multiple psychedelic assisted therapy approaches including Psilocybin- Assisted Therapy for Depression (COMPASS Pathways) and 5-MEO-DMT-Assisted Therapy for Depression (Beckley PsyTech). Joseph is deeply passionate about furthering education and awareness of the healing benefits of psychedelics for communities of color and in working to improve mental health outcomes for historically underserved communities.
Joseph received his undergraduate degree in psychology from the University of California, Santa Barbara, and his doctorate in clinical psychology from the Chicago School of Professional Psychology.
What does it take to build a psychedelic therapy practice that is sustainable, ethical, and aligned with your clinical values? In this live webinar hosted on Riverside (a Zoom alternative), Fluence’s Director of Product, Dan MacCombie will sit down with Chantelle Thomas, PhD, a psychologist and experienced ketamine-assisted psychotherapy (KAP) provider, for a grounded and candid conversation about practice-building in the evolving world of psychedelic therapy. Dr. Thomas brings extensive experience as a clinician, program director, and clinical researcher, with a background in both residential addiction treatment and psychedelic-assisted therapy. Her work blends psychological depth, systems thinking, and real-world experience navigating ethical and logistical complexities in practice. This CE-granting session offers real-world insights for clinicians who are curious about:How to build a practice that centers care, integrity, and responsibilityNavigating scope of practice, licensure, and regulatory considerationsBalancing sustainability and accessibility in service deliveryWays structure can support or undermine the therapeutic frameCommon questions from new KAP providers entering the fieldThe webinar will conclude with a live Q&A.
A recording will be sent to all registrants, so feel free to sign up even if you cannot attend live.
Date: September 4th, 2025 | WednesdayTime: 11 AM - 12 PM ETHosted by: Dan MacCombie, MA, LPC, Director of Product at Fluence
Special Guest: Chantelle Thomas, PhD
Format: Live Webinar via Riverside
CE Credit Available: 1 CE Hour
Curious about training in psychedelic therapy but unsure where to begin?
We’d love to help you gain clarity on how one of our courses fits into your path. Schedule a free 1-on-1 info call with Kabir Cooppan-Boyd, Marketing & Communications Manager at Fluence, dedicated to guiding you on your learning journey.
During your call, Kabir can answer your questions and explain how our courses connect to professional certificates in:
Psilocybin Facilitation
Ketamine-Assisted Psychotherapy
Psychedelic Harm Reduction and Integration
If you’re a clinician with questions or curiosity about our programs, this personalized conversation is the perfect way to find your best next step.
Schedule your free 1-on-1 call with Kabir
Start your journey now and move toward certification in Psilocybin Facilitation, Ketamine-Assisted Psychotherapy, or Psychedelic Harm Reduction and Integration at the current, lower rate.
All certificate programs start with our six-week Essentials of Psychedelic Therapy course, with the September cohort taught by Joseph McCowan, PsyD and Mia Sarno, PsyD.
Certificate Programs
Psilocybin Facilitation
Sep 9, 2025 - Apr 11, 2026
Ketamine-Assisted Psychotherapy
Sep 9, 2025 - Apr 14, 2026
Psychedelic Harm Reduction and Integration Therapy
Sep 8 - Dec 8, 2025
Standalone Courses
Psychedelics and Psychoanalysis
Oct 16 - Dec - 11, 2025
Expanding the Self: Buddhism and Psychedelic Therapy
Sep 24 - Nov 19, 2025
Ibogaine highlighted by former Senator Kyrsten SinemaFormer U.S. Senator Kyrsten Sinema is publicly advocating for ibogaine, positioning FDA approval as a transformative pathway for PTSD, Parkinson’s, and TBI. She’s now outlining strategic proposals to fund research and regulatory groundwork.
Federal bipartisan shift in psychedelic advocacyA surprising coalition has emerged: Trump-aligned figures like RFK Jr. and HHS leadership alongside Bay Area progressives are now supporting federal psychedelic policy reform, especially for PTSD treatments. While they emphasize the need for rigorous research and safety standards, this marks a meaningful shift in national momentum.
DA Opens Pilot Run of Commissioner Voucher ProgramThe FDA has officially launched a pilot of its Commissioner’s National Priority Voucher (CNPV) program, offering dramatically shortened review timelines (1–2 months vs. 10–12) for drug and biologic developers that align with national priorities like affordability, domestic production, or unmet medical needs. This initiative presents psychedelic therapy developers, especially those addressing treatment-resistant conditions and innovating around durable relief, with a potential fast-track regulatory route that could accelerate time to market.
