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Psychedelic Bulletin #142: Terran’s IP Portfolio; AMA Advocates Against Non-Medical Psychedelics; Couple Receives First Psilocybin Services in Oregon; Mass. Ballot Measure Ramps Up; NIDA and NIMH Directors Opine

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The Directors of the National Institute on Drug Abuse (NIDA) and National Institute of Mental Health (NIMH)—billion dollar government research agencies—shared their thoughts on the Potential and Challenges of Psychedelics as Therapeutics in a recent Viewpoint published in JAMA Psychiatry.

The Viewpoint suggests that they’re keen to temper hype around psychedelics. “Despite the promising early results,” they write, “it is clear that psychedelics are not wonder drugs, but the hype has gotten ahead of the science.” They say that this is “reminiscent of what happened with medical cannabis”, whereby—in their interpretation, at least—“regulations pertaining to its medical use were approved, promoting a booming cannabis industry, despite lack of scientific evidence for its therapeutic efficacy.”

The National Institutes of Health (NIH), which oversees the work of agencies such as NIMH and NIDA, is funding over seventy active projects on the therapeutic use of psychedelics, the Viewpoint notes.

In terms of research priorities, the article highlights a handful of areas in which further research is warranted.

Unsurprisingly, given recent research and funding attention, evaluating the potential for non-hallucinogenic psychedelics is high up on the agenda. “An important research question is whether the subjective experiences associated with psychedelic drugs are intrinsic to or separable from their therapeutic effects”, they note.

While they acknowledge there is “evidence to suggest that psilocybin’s therapeutic efficacy is tied to the mystical-type experiences it commonly precipitates”, they then say that this connection “remains controversial”.

Alluding to research and development of psychoplastogens, they note that groups are “exploring whether desired (eg, depression-ameliorating) neuroplastic effects can be decoupled from the cognitive and sensory distortions that raise questions about the safety of psychedelic drugs.”

Next, the authors acknowledge the role of set and setting in psychedelic therapy, describing these contextual factors as playing a “significant role”. However, they note the lack of standard protocols for facilitation of psychedelic therapy and note that “there have been no rigorous tests” of whether a clinician’s “time and attention accounts for a nontrivial component of psychedelics’ therapeutic effects”.

Next, they survey some of the unique challenges faced by those running psychedelic trials. The first is perhaps the most obvious: administrative hurdles arising from psychedelics’ Schedule I status.

The second challenge identified by the authors is related to difficulties in finding adequate placebo controls. Again, no surprises here.

The authors suggest that greater “standardization and harmonized protocols for clinical trials are needed so that results can be compared, along with longer follow-up studies to understand long-term outcomes.”

Moving on to more commercialisation-related matters, the Viewpoint explains that a Risk Evaluation and Mitigation Strategy (REMS) will be needed in order to gain FDA approval before going on to discuss reimbursement. The authors go on to explain that “it will be helpful for regulators and payers to articulate the evidence required for drug approval and reimbursement determinations so that researchers can design responsive trials.”

On this topic, the authors later write that “[i]t is crucial that psychedelic-assisted treatments, if they become available, are available to everyone. That means they should be affordable.” Beyond the direct costs of the intervention that might be borne by a patient, they also point out that “given how time intensive the therapy may be, there should be accommodations for people with work, family, or transportation challenges.”

Further challenges for psychedelic research include the “baggage of past ethical transgressions, including egregious experimentation with LSD on unwitting study ‘participants’”. This recent history “places a unique burden on researchers to be transparent in their aims and methods”, the pair posit.

Because of this history, “people from racial and ethnic minoritized groups may be particularly hesitant to participate”; and yet, “inclusion of diverse study populations is necessary to ensure that findings are applicable across individuals with varying demographic characteristics.”

On the topic of patient vulnerability during the psychedelic experience, the Viewpoint explains that “the clinical staff’s role needs to be structured in ways that prevent possible abuses.”

“Answering the open questions and developing necessary structures will be a prerequisite to the eventual FDA approval, scaling-up, and reimbursement of these treatments”, the pair explain.

In an interesting admission, they go on to draw further parallels to cannabis. “Based on the experience with cannabis,” they write, “it is also likely that psychedelics will be used for therapeutic purposes even without FDA approvals and that if states legalize their use for medical purposes, there will also be an increased use for wellness or recreational purposes.” With this in mind, they argue that research “that informs about benefits and risks from such patterns of use will be necessary to guide public health policies.”

The short Viewpoint ends on a measured yet optimistic note. “Challenges notwithstanding, the promise of psychedelics research goes beyond the promise of new pharmacotherapies”, they pronounce.

Expanding on this point, they note that a “[b]etter understanding of the mechanisms by which psychedelics may increase resilience could be highly valuable.”

“Besides telling us about the neurobiology of resilience, such research might facilitate development of alternative treatment modalities (eg, neuromodulation) that could provide similar benefits for patients.”

(Our Editor Josh Hardman also covered the piece on Twitter.)

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