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Cited by 322Psychedelics and Drug StudiesAlkaloids: synthesis and pharmacologySynthesis and bioactivity of alkaloids

Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

McKenna, Dennis J·2004·Pharmacology & Therapeutics
DOI 10.1016/j.pharmthera.2004.03.002
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Abstract

Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

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  • After an approximately 35 to 40-min latency period, ayahuasca consumption induces an intense modified state of consciousness that lasts approximately 4 h.

    “After an approximately 35 to 40-min latency period, the consumption of ayahuasca induces an intense modified state of consciousness that lasts approximately 4 h (McKenna, 2004).”

    From The therapeutic potentials of Ayahuasca: possible effects against various diseases of civilization (2016) · cites this paper as McKenna, 2004

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Authors
McKenna, D. J.
Affiliations
University of Minnesota (US)
Corresponding author
McKenna, Dennis J
Venue
Pharmacology & Therapeutics
Publisher
Elsevier BV
Published
2004-05
Volume
102
Issue
2
Pages
111-129
ISSN
0163-7258 (ISSN-L)
DOI
10.1016/j.pharmthera.2004.03.002
OpenAlex
W2161026846
Cited by
321
References
103
Citations by year
2026: 7 · 2025: 11 · 2024: 16 · 2023: 9 · 2022: 23 · 2021: 17 · 2020: 33 · 2019: 12 · 2018: 22 · 2017: 15 · 2016: 19 · 2015: 18 · 2014: 15 · 2013: 12 · 2012: 20
FWCI
0.85
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Pharmacology & Therapeutics (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Alkaloids: synthesis and pharmacology
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Synthesis and bioactivity of alkaloids
Keywords
ayahuasca, N,N-dimethyltryptamine, monoamine oxidase inhibition, β-carbolines, ayahuasca tourism, Religious Freedom Restoration Act, União do Vegetal, alcoholism treatment, addiction treatment, clinical research regulation, Schedule I controlled substances, hallucinogens
MeSH terms
Brazil, Clinical Trials as Topic, N,N-Dimethyltryptamine, Humans, Legislation, Drug, Phytotherapy, Plant Extracts, Psychotropic Drugs, United States, United States Food and Drug Administration, Molecular Structure, Banisteriopsis

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