Three Johns Hopkins Psychedelics Professors Call The Shots On Live Q&A: Knowns, Unknowns, Regulations & Hopes

Johns Hopkins University’s new congressional briefings series chapter, “What’s next for psychedelics,” covered a wide range of topics including clinical research specificities, therapists' training, policy hurdles, potential economic impact and necessary safeguards.

The session was led by Frederick Barrett, Sandeep Nayak (both, JH School of Medicine) and Matthew Eisenberg (JH Bloomberg School of Public Health) and moderated by Lainie Rutkow (vice provost for Interdisciplinary Initiatives.) More below.

Real-World Use And Risk Mitigation

Director of the university’s Center for Psychedelic & Consciousness Research (CPCR,) Barrett told attendees that in addition to conducting prominent research since the early 2000s, the center focuses on understanding psychedelics’ risks and their potential mitigation -both within controlled clinical settings and out in the world.

Despite existing research hurdles, Barrett believes the U.S. regulatory landscape holds numerous “good aspects and features,” and although very restrictive and not perfect, all work toward safety. 

“I think we need to acknowledge that, and also be careful not to dismantle any kind of regulatory structures that would lead to increased harm. That's really the bottom line.”

Referring to the recently filed bipartisan and bicameral proposal for Schedule 1 drugs holding FDA’s Breakthrough Therapy designation to be automatically moved to Schedule 2, he says the rationale behind it is that Schedule 1 drugs are by definition toxic, addictive and have no known medical use, while the BT designation is “an acknowledgment of an up and coming drug that shows a really high degree of early effect sizes and great potential.”

Ultimately, psilocybin and MDMA rescheduling would have minimal impact on their accessibility outside controlled settings, but should "greatly increase the feasibility” of conducting research with "a net outcome of an overall increased safety."

Treatment Specificites And Addiction Peril

Clinical director at CPCR, Nayak leads trials on psilocybin for opioid use disorder and PTSD and has experience in studies on depression, substance use disorders, OCD and anorexia. 

From a psychiatrist’s perspective, he said what's most compelling and interesting about psychedelic treatments is that “when they work, they tend to work quickly” following administration “one to a handful of times” -almost unprecedented in conventional psychiatric or psychological treatments. 

The field, he said, tends to consider it as a kind of drug-assisted psychotherapy -an intervention with powerful drug and psychological effects rather than mere molecules affecting people in a uniform way. 

As much as psychedelic-assisted therapy differs from regular, conventional clinical, psychiatric or psychotherapeutic care, Nayak said he was impressed by “how similar and how familiar it is, and how it can actually be resolved or boiled down into psychotherapeutic processes that would happen normally in psychotherapy, or for the acute drug effects not so different from dealing with things you might see in psychiatry.” 

Regarding addiction to psychedelics, as drugs behave differently, the “classic addiction” pattern of ingesting escalating amounts until an eventual loss of control can be found with alcohol, opioids and benzodiazepines, psychedelics like LSD and psilocybin, their “very rapid tolerance” do not usually lead to ingesting repeated doses.

Nonetheless, Nayak echoed Barrett’s caution: “There are pretty substantial risks,” which are known, and can be managed “with appropriate patient selection in a carefully monitored environment.”

Cannabis Parallels And Commercial Viability 

Eisenberg, economist and director at JH’s Center for Mental Health and Addiction Policy, says a comparison between psychedelics and cannabis in policy, social acceptance and commercial aspects brings up both similarities and differences.

Similarities include their historically strict regulatory classifications for possession and use. Marijuana’s past 15-year path has greatly influenced public perception and policy, potentially creating "a partial blueprint" for psychedelics. 

Differences mainly involve marijuana’s broad medical and additional applications, while psychedelics are primarily used for specific treatments under controlled healthcare settings. 

Eisenberg says marijuana really took a dual pathway with commercialization via the medical form and the promise of recreational legalization, leading to broad commercialization and wide market penetration across the country. 

Unlike a consumer-focused model, psychedelics' administration requires nursing professionals, likely leading to more direct integration into the healthcare system -either through pharmaceutical or in-person care models.

Insurance companies' reply to such integration, important once federal legalization happens, will likely provoke some hassle as per the treatment's novelty and some of the evidence’s recency, Eisenberg said.

And yet, he foresees a gradual shift will begin to take place in these companies’ mindset, which might, in turn, change how mental health coverage is structured, as a longer-term treatment vs. psychedelics’ research shows a shorter-than-standard course can be more efficacious and cost-saving. 

Photo courtesy of Art Anderson.