Guidelines for Establishing Safety in Ayahuasca and Ibogaine Administration in Clinical Settings
Psychoactives – December 11, 2023
Source: OpenAlex
Summary
A comprehensive set of guidelines has been developed to ensure the safety of participants in clinical trials involving psychedelics like ayahuasca and ibogaine. With an increasing number of individuals presenting varied medical conditions, these protocols aim to address potential adverse effects, including psychiatric issues such as panic attacks (reported in 20% of cases) and clinical manifestations like hypertensive crises (observed in 10%). Crafted through collaboration with specialists and extensive literature review, these guidelines enhance the safety and management of psychedelic research at the University of São Paulo’s LEAPS laboratory.
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).