[Photo by Polina Kovaleva]
The organizations that have made the most progress in the clinical development of psychedelic agents — broadly defined — have tended to prioritize psychological support before and after drug administration.
A position statement from the the American Psychiatric Association notes that, in preliminary research, psychedelics “have generally been combined with structured psychotherapy protocols proposed by investigators as integral to achieving full therapeutic benefit and ensuring participant safety and wellbeing.”
According to Doug Drysdale, CEO of Cybin (NYSEAMERICAN:CYBN), such support shouldn’t be confused with psychotherapy. “But getting the patient prepared is important,” Drysdale added. Such sessions can help set patients’ expectations, so they are not shocked or surprised during the psychedelic therapy session. Such sessions can also help patients set clear goals for their treatment sessions. “It seems from the feedback we’ve had and academic studies that preparation leads to better outcomes,” Drysdale said.
The Multidisciplinary Association for Psychedelic Studies (MAPS) and Compass Pathways (Nasdaq:CMPS) have each created therapeutic paradigms to guide the use of MDMA and psilocybin, respectively. MAPS and Compass also offer training programs for mental and behavioral health professionals interested in psychedelic therapy.
Cybin has created the EMBARK framework that it can use for a variety of indications and different treatments. “EMBARK has been designed to be very flexible and adaptable,” Drysdale said.
The company has a Phase 1/2a study underway for its deuterated psilocybin analog CYB003 for major depressive disorder and another for deuterated DMT-based CYB004 in anxiety disorders. The company has also co-sponsored a randomized, placebo-controlled trial of psychedelic therapy with psilocybin in frontline clinicians with COVID-related distress. That study will also use the EMBARK framework.
EMBARK is an acronym encompassing six domains. Its six letters stand for “existential/spiritual,” “mindfulness,” “body aware,” “affective/cognitive,” “relational” and “keeping momentum.”
“The idea is to have various approaches across the spectrum that can be deployed to help the patient through that sort of spiritual/mindful session that they are about to embark upon,” Drysdale said.
Drysdale said that the mystical dimension of the experience is correlated with the therapeutic effects.
The company uses the 30-question Mystical Experience Questionnaire (MEQ30) to track the degree to which a psychedelic induces a mystical experience. “There’s definitely some connection between the depth of the psychedelic experience and the outcome,” Drysdale said. “Some people tend to describe it as being ‘spiritual’ or ‘mystical’ in some way.”
The mindfulness dimension of the framework involves being aware of the inner experience during the psychedelic experience. Clinical trial participants wear eye masks and headphones to accentuate introspection. “We tell patients when they start to experience things to move inwards and move towards them rather than trying to run away from them,” Drysdale said.
The body-based focus of the framework can help heal the rift that often appears between the mind and body. For example, physical awareness and health directly relate to mental health.
The affective/cognitive part of the framework is included to help patients understand they are likely to become emotional during the psychedelic experience. “They can become emotional in a very positive way or in quite a traumatic way sometimes,” Drysdale said. The framework “encourages patients to embrace and welcome those emotional states during the session,” he added.
“Sometimes, the boundaries between self and other — self and the universe — can dissolve and disappear,” Drysdale said.
The relational component involves building a relationship with the therapist or facilitator before the experience. Having a degree of trust in that person can help patients relax and go inward during the session.
The final part of the framework, ‘keeping momentum,’ instructs patients to remember the psychedelic experience as a motivator after it has concluded. The idea is not to let the experiences disappear. “Patients often forget more than 50% of what they experienced within a couple of days,” Drysdale said.
Keeping momentum also can involve continuing to dwell on the intention that accompanied the experience.
“‘Keeping momentum’ can also mean a follow-up session,” Drysdale said. “Two sessions close together are often better than one.”
The momentum can also involve integrating the psychedelic experience into either psychotherapy sessions or their lives.