Psychedelics: Science sabotaged by Social Media

Developing microdoses of psychedelics could overcome many scientific and regulatory hurdles that hinder high-dose psychedelic drug development. If microdosing proves efficacious and safe for long-term use, it could be administered through the typical outpatient model for mental disorders, which would be more cost-effective than the high-dose/intense psychotherapy model. Outpatient psychotherapeutic agents have a clear approval route and would likely avoid the extensive Risk Evaluation and Mitigation Strategy required for high-dose use. The article suggests there may be different therapeutic roles for both high and low dose psychedelic agents.

Study at a glance

Abstract

The substantial challenges facing high and low dose psychedelic drug development to achieve regulatory approval have been documented in the scientific literature. These limitations have not deterred drug developers and social media from repeatedly misleading patients, the public and health professionals. Developing "micro doses" of psychedelics overcomes many of the scientific and regulatory challenges of high dose psychedelics. If micro-dosing could be shown to be efficacious and safe for long term use, it could be administered in the typical model for treatment of mental disorders. Such a model would be more cost effective than the high dose/intense psychotherapy model currently described and could be readily available to all individuals who need another medication option. Outpatient psychotherapeutic agents have a clear route for approval and would be unlikely to be burdened by the extensive Risks Evaluation and Mitigation Strategy needed for high dose use. There may be a different therapeutic role for both high and low dose psychedelic agents. This article is part of the Special Issue on "National Institutes of Health Psilocybin Research Speaker Series".