Abstract The global expansion of psychedelic research, clinical translation, and policy reform has intensified debates concerning safety, equity, cultural appropriation, and Indigenous rights. A prominent contribution to these discussions is the Hopkins–Oxford Psychedelic Ethics (HOPE) Consensus Statement (Jacobs et al., 2024), which proposes a foundational ethical framework for a field...
Psychedelic-assisted therapy (PAT) has typically been evaluated using conventional randomised controlled trials (RCTs), which assess treatment efficacy under highly controlled conditions. However, PAT constitutes a complex intervention, integrating pharmacological, psychotherapeutic and contextual elements that interact dynamically with patient experiences and healthcare settings. Conventional...
ABSTRACT The recent review of a new drug application for MDMA‐assisted therapy for posttraumatic stress disorder by the United States' Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early‐ and late‐stage development, like psilocybin for depression. The...
The recent review of a new drug application for MDMA-assisted therapy for post-traumatic stress disorder by the United States’ Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early- and late-stage development, like psilocybin for depression. The...
Ayahuasca is a beverage used in Amazonian traditional medicine and it has been part of the human experience for millennia as well as other different psychoactive plants. Although Ayahuasca has been proposed as potentially therapeutic as an anxiolytic and antidepressant, whilst no studies have been carried out so far investigating their direct effect on brain emotional processing. This study...
The call for rigor by van Elk and Fried 1 is a welcome contribution to psychedelic research.The authors emphasized the well-known principles of internal, external, and construct validities, highlighting that conclusions should not extend beyond robust statistical inferences.The examples of previous inadequacies and mistakes regarding some of these principles, including oversight by peer...
The validated scale showed solid psychometric properties, with potential differences in factor structure in relation to the English version. Considering validation is an ongoing process, it is recommended that studies be conducted comparing ego dissolution scores across distinct substances and different regions of the country.
This study sought to investigate the effects of different substances on nature relatedness (NR) in the general population. An online cross-sectional survey done in Brazil investigated use of ayahuasca/DMT, psilocybe mushrooms, LSD, MDMA/ecstasy, cocaine, cannabis, and alcohol. NR was assessed using the short-form version of the nature related scale (NR-6). One-way analysis of variance (ANOVA)...
After decades of biomedical research on ayahuasca's molecular compounds and their physiological effects, recent clinical trials show evidence of therapeutic potential for depression. However, indigenous peoples have been using ayahuasca therapeutically for a very long time, and thus we question the epistemic authority attributed to scientific studies, proposing that epistemic injustices were...
Since a 1957 exposé in Life Magazine, chemical compounds derived from Psilocybe mushrooms have been the focus of dozens of attempted and successful patents, most recently to treat depression. Regrettably, the Mazatec indigenous communities who stewarded these traditional medicines for millenia are not party to any of these patents, despite a number of international treaties asserting indigenous...
Lysergic acid diethylamide (LSD), the prototypical “psychedelic,” may be unique among psychoactive substances. In the decades that followed its discovery, the magnitude of its effect on science, the arts, and society was unprecedented. LSD produces profound, sometimes life-changing experiences in microgram doses, making it a particularly powerful scientific tool. Here we sought to examine its...
Mental disorders are rising while development of novel psychiatric medications is declining. This stall in innovation has also been linked with intense debates on the current diagnostics and explanations for mental disorders, together constituting a paradigmatic crisis. A radical innovation is psychedelic-assisted psychotherapy (PAP): professionally supervised use of ketamine, MDMA, psilocybin,...
Objective This report documents the phenomenology of the subjective experiences of 22 patients with substance-related disorders who were involved in a treatment combining cognitive–behavioral therapy and hospital sessions with ibogaine in Brazil. Methods Participants underwent a one-to-one semi-structured interview exploring the subjective effects of ibogaine. We employed interpretative...
Substance use disorders are important contributors to the global burden of disease, but current treatments are not associated with high rates of recovery. The lack of approved and effective treatments is acutely problematic for psychostimulants like cocaine and crack cocaine. One promising alternative in the treatment of drug dependence in general and psychostimulants in particular is the use...
Background: The States of Consciousness Questionnaire (SOCQ) was developed to assess the occurrence features of the change in consciousness induced by psilocybin, and includes the Mystical Experience Questionnaire (MEQ), developed to assess the ocurrence of mystical experiences in altered states of consciousness. Objective: To translate the SOCQ to Brazilian Portuguese and validate the 30-item...
Ritual use of ayahuasca, an amazonian Amerindian medicine turned sacrament in syncretic religions in Brazil, is rapidly growing around the world. Because of this internationalization, a comprehensive understanding of the pharmacological mechanisms of action of the brew and the neural correlates of the modified states of consciousness it induces is important. Employing a combination of...
Data from EEG recordings and plasma samples from volunteers who took ayahuasca in an experiment aproved and conducted at Federal University of São Paulo. Under review at PLOS ONE
Ibogaine is an alkaloid purported to be an effective drug dependence treatment. However, its efficacy has been hard to evaluate, partly because it is illegal in some countries. In such places, treatments are conducted in underground settings where fatalities have occurred. In Brazil ibogaine is unregulated and a combined approach of psychotherapy and ibogaine is being practiced to treat...
Between April and October 2024, expert bodies in two countries reached strikingly opposite conclusions about the therapeutic use of 3,4-methylenedioxymethamphetamine (MDMA). On the one hand, the Food and Drug Administration in the USA rejected a formal New Drug Application from a specific drug sponsor, Lykos Therapeutics, for Post-Traumatic Stress Disorder (PTSD). The decision was surprising to...