Translating Psychedelic Therapies From Clinical Trials to Community Clinics: Building Bridges and Addressing Potential Challenges Ahead

Abstract

Research exploring the potential of psychedelic-assisted therapies to treat a range of mental illnesses is flourishing, after the problematic sociopolitical history of psychedelics led to the shutdown of clinical research for almost 40 years. Encouraged by positive results, clinicians and patients are now hopeful that further interruptions to research will be avoided, so that the early promise of these therapies might be fulfilled. At this early stage of renewed interest, researchers are understandably focusing more on clinical trials to investigate safety and efficacy, than on longer-term goals such as progression to community practice. Looking to identify and avoid potential pitfalls on the path to community clinics, the authors, a group of Australian clinicians and researchers, met to discuss possible obstacles. Five broad categories of challenge were identified: 1) inherent risks; 2) poor clinical practice; 3) inadequate infrastructure; 4) problematic perceptions; and 5) divisive relationships and fractionation of the field. Our analysis led us to propose some strategies, including public sector support of research and training to establish best practice and optimize translation, and funding to address issues of equitable access to treatment. Above all, we believe that strategic planning and professional cohesion will be crucial for success. Accordingly, our key recommendation is the establishment of a multidisciplinary advisory body, broadly endorsed and representing all major stakeholders, to guide policy and implementation of psychedelic-assisted therapies in Australia. Although these challenges and strategies are framed within the Australian context, we sense that they may generalize to other parts of the world. Wherever they apply, we believe that anticipation of potential difficulties, and creative responses to address them, will be important to avoid roadblocks in the future and keep the “psychedelic renaissance” on track.

Virtual Reality as a Moderator of Psychedelic-Assisted Psychotherapy

“…Psychedelic-assisted psychotherapy presents itself as a promising and attractive alternative to established psychiatric treatments (Nichols, 2016;Belouin and Henningfield, 2018). The recent revival in research on therapies that use psychedelics highlights a unique set of benefits, along with a unique set of challenges and limitations of this approach (Wheeler and Dyer, 2020;Williams et al, 2021). In parallel, VR is reportedly one of the most enjoyable and comfortable forms of therapy (Garrett et al, 2017), having one of the highest compliance rates and best therapeutic alliance across all forms of treatments (Meyerbröker and Emmelkamp, 2008;Wilson et al, 2008), even among individuals resistant to other treatments (Riva et al, 2019).…”

Safety considerations in the evolving legal landscape of psychedelic-assisted psychotherapy

“…As evidence accrues and access to PAP improves, Canadians welcome the recent SAP amendments to reinstate emergency medical exemptions for psychedelics [ 13 ]. Nevertheless, a calculated approach is essential to translate rapidly evolving evidence into best practices and keep the “psychedelic renaissance on track.” [ 4 ] On a systems level, similar to the mandate of the Oregon Psilocybin Services Act, coordinated efforts are needed to establish regulating authority to define and evaluate PAP including patient safety and practice standards [ 22 ]. In this pursuit, capacity building in training and licensing is urgently needed [ 23 ], especially as demands increase with broader implementation of PAP.…”

Unraveling the Mysteries of Mental Illness With Psilocybin

“…For example, the National Institutes of Health (NIH) did not fund any grants specifically involving psychedelic clinical trials from 2006 to 2020 [ 102 ]. This period encompasses many successful government-funded clinical trials worldwide, including in Australia, Canada, Israel, New Zealand, and the United Kingdom, that have supported this research field [ 103 - 105 ]. As of this writing, the NIH has now funded a joint study between Johns Hopkins University, the University of Alabama, and New York University to study psilocybin as a therapeutic intervention for tobacco use disorder - the first US federal grant in 50 years for psychedelic treatment [ 106 ].…”