BR
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Active Trials
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Brazil

Mixed (regulated medical + research + religious exemptions)

Reimbursed Care Access

Brazil maintains a mixed regime: esketamine is a registered medicine with clinical use in specialized settings while ketamine is widely used off‑label in private practice; classic psychedelics (psilocybin, MDMA, DMT, mescaline and many synthetic tryptamines) remain controlled under national drug law and Portaria 344 but some clinical research has been pursued under Anvisa/ethical-authority authorizations; ayahuasca is explicitly authorized for ritual/religious use under CONAD decisions.

📜History of research in Brazil

Psychedelic substances have a long and layered history in Brazil that blends Indigenous, syncretic-religious and biomedical trajectories. Indigenous Amazonian groups have used ayahuasca (hoasca, caapi) and other plant medicines for centuries within ritual and healing contexts; these practices were later integrated into syncretic churches such as Santo Daime and União do Vegetal (UDV) in the 20th century. The entry of classical psychedelics into scientific and psychiatric discourse followed the global pattern: Albert Hofmann's discoveries in Switzerland (LSD in 1938 and the isolation/synthesis of psilocybin in 1958) helped trigger international research in the post-war decades, and Sandoz’s distribution of compounds like LSD made such agents available to researchers worldwide during the 1950s and 1960s.

From the 1970s onward, international scheduling (notably the 1971 UN Convention on Psychotropic Substances) and national controls reduced mainstream clinical research globally and in Brazil. Nevertheless, Brazil’s particular cultural and legal environment — including constitutional protections for freedom of religion (1988) — created a context in which religious use of ayahuasca persisted and attracted anthropological, pharmacological and clinical attention. Over the last two decades Brazilian universities and hospitals have established sustained research programmes examining ritual use, psychopharmacology, neuroimaging and the therapeutic potential of ayahuasca, producing a distinctive literature that links ethnography, basic science and clinical research.

A major turning point for Brazilian clinical research came with rigorously designed trials and neurobiological studies led by academic groups in São Paulo, Rio de Janeiro and other centres. Notably, a randomised placebo-controlled trial published in 2019 demonstrating rapid antidepressant effects of ayahuasca in treatment-resistant depression elevated international recognition of Brazil’s scientific leadership on this compound. Since then, Brazilian teams have expanded neuroimaging, biomarker and longitudinal studies while also engaging with global debates on safety, ethics and regulatory pathways for research with classic and entactogenic psychedelics.

Today the research landscape in Brazil is plural and pragmatic: robust expertise exists around ayahuasca in clinical and naturalistic settings, while nascent activity addresses psilocybin, MDMA and other agents. Research is tightly regulated through Brazil’s ethical review system and ANVISA (the national health surveillance agency); investigators routinely navigate complex intersections of religious practice, indigenous knowledge and biomedical research ethics.

🔬Research Focus

Brazilian research strengths remain concentrated on ayahuasca (a brew containing DMT and monoamine oxidase inhibitors) across multiple domains: clinical trials for mood disorders (particularly treatment-resistant depression), observational studies of long-term ritual use, neuroimaging investigations of acute and subacute brain effects, and biomarker studies that probe inflammatory and neuroplasticity-related mechanisms. The availability of large populations practising ritual use provides a distinctive naturalistic cohort resource that complements controlled clinical work.

Beyond ayahuasca, interest in psilocybin (for depression, end-of-life distress and substance use disorders) and MDMA-assisted therapy (for PTSD) is growing but remains at an earlier stage; most activity so far comprises preclinical work, feasibility studies, protocol development and ethical/regulatory scholarship. Ketamine and esketamine research for depression is well established clinically in Brazil and informs mechanistic and implementation studies that are relevant to the broader psychedelic therapy field. Overall, the priorities reflect a balance between the country’s cultural legacy with plant medicines and an emerging engagement with international clinical agendas for psilocybin and MDMA.

🏆Key Milestones

1938
Albert Hofmann synthesised lysergic acid diethylamide (LSD) at Sandoz, initiating the modern era of psychedelic research.
1958
Albert Hofmann isolated and synthesised psilocybin, expanding scientific access to classic serotonergic psychedelics.
1971
The UN Convention on Psychotropic Substances was adopted, leading to global scheduling regimes that constrained clinical research and non-medical use.
1988
Brazil’s Federal Constitution enshrined freedom of religion, which contributed to legal protections and social recognition for ritual ayahuasca use by syncretic churches.
2006
The US Supreme Court decision in Gonzales v. O Centro (involving the UDV) affirmed religious use protections for ayahuasca in the United States; the case had transnational significance for recognition and legal debate around hoasca/ayahuasca.
2019
A randomised placebo-controlled clinical trial published by a Brazilian team reported rapid antidepressant effects of ayahuasca in treatment-resistant depression, marking a high-profile scientific milestone.
2020
Academic and clinical interest in psilocybin and MDMA increased in Brazil, with multiple institutions developing protocols, ethics guidance and early-stage feasibility work.

🚀Future Outlook

Over the next 12–24 months Brazil is likely to see incremental expansion of regulated clinical research beyond ayahuasca into psilocybin and MDMA, primarily via academically led trials and international collaborations. Researchers will continue to work within ANVISA and national ethics procedures (CONEP and local IRBs) to secure approvals; expect more phase II-style studies, pilot protocols and formalised data on safety, dosing and implementation in Brazilian clinical settings. Training programmes, clinical guidelines and institutional review experience will grow as a result.

Regulatory clarity is likely to advance cautiously rather than rapidly: ANVISA will remain central to authorising clinical work and imports/manufacture of controlled compounds, and legal recreational liberalisation is unlikely in the near term. Key near-term developments will therefore be procedural — improved regulatory pathways for clinical research, emergence of standardised research-grade supply chains, strengthened ethical frameworks for studies involving ritual communities and indigenous knowledge, and deeper international academic partnerships.

Clinical Trials in Brazil

Research Events

Organizations2