Guidelines for Establishing Safety in Ayahuasca and Ibogaine Administration in Clinical Settings
About the study
The article begins by discussing the growing research interest in psychedelic substances, particularly ayahuasca and ibogaine, and highlights the lack of specialized literature on safe management procedures in clinical trials involving these psychedelics.
The research team designed guidelines for managing adverse scenarios in clinical trials involving ayahuasca and ibogaine. These include detailed protocols for participant screening and selection, medication management, and procedures during and after the experimental session. Special emphasis is placed on the setup of the experimental environment, the approach to participants, and the management of potential adverse events.
The authors highlight the need for continuous updates and improvements to these guidelines based on evolving scientific knowledge. The article serves as a comprehensive source of information and guidance for safely conducting clinical trials with ayahuasca and ibogaine, emphasizing the need for standardized care and procedures.
Abstract
As the research field with psychedelic substances grows, it is expected to encompass a more extensive cohort of individuals presenting a spectrum of medical conditions, comorbidities, and unique physiological traits, thereby increasing the likelihood of potential adverse events. Furthermore, it is worth noting that there is a scarcity of the specialized literature regarding procedures to ensure the safe management of clinical trials involving psychedelics. Acknowledging this, our research team designed a series of protocols to standardize the care and management of adverse scenarios, ensuring the safety and well-being of research volunteers included in clinical trials conducted by the LEAPS (Laboratory for Studies with Hallucinogens and Psychedelics in Mental Health, linked to the University of São Paulo). These guidelines have been meticulously crafted based on the established guideline philosophy of Hospital das Clínicas de Ribeirão Preto (the university hospital of Universidade de São Paulo), consultation with specialists in the field, and a thorough review of the existing literature. The process resulted in protocols that have been tailored to specifically address the unique requirements and particularities of clinical research with psychedelic substances (in this case, ayahuasca and ibogaine). As a result, these guidelines aim to cover a range of potential issues, encompassing both psychiatric manifestations (e.g., panic attacks, suicidal behavior, and psychotic episodes) and clinical manifestations (e.g., hypertensive crisis and hypoglycemia).
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