Trial reportPsychopharmacology2012
Pharmacology of ayahuasca administered in two repeated doses.
Trial report in Psychopharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05894902 (Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults), which is not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
Who cites it
55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 138 citations in OpenAlex.
- Antidepressive and anxiolytic effects of ayahuasca: a systematic literature review of animal and human studies.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) · 2016Pooled it
- Ayahuasca and Dimethyltryptamine Adverse Events and Toxicity Analysis: A Systematic Thematic Review.International journal of toxicologyPooled it
- Pharmacokinetics and pharmacodynamics of an innovative psychedelic N,N-dimethyltryptamine/harmine formulation in healthy participants: a randomized controlled trial.The international journal of neuropsychopharmacology · 2024Trial
- Overcoming Pharmacokinetic and Peripheral Safety Challenges in Psychedelic Therapies: The Promise of Advanced Drug Delivery Systems.ACS pharmacology & translational science · 2026Review
- 5-MeO-DMT: An atypical psychedelic with unique pharmacology, phenomenology & risk?Psychopharmacology · 2025Review
- Ayahuasca enhances the formation of hippocampal-dependent episodic memory without impacting false memory susceptibility in experienced ayahuasca users: An observational study.Journal of psychopharmacology (Oxford, England) · 2025Observational
- A prospective ecological momentary assessment study of an ayahuasca retreat: exploring the salutary impact of acute psychedelic experiences on subacute affect and mindfulness skills in daily life.Psychopharmacology · 2025Article
- The influence of stakeholder interests on safety outcome reporting in psychedelic research and implications for science communication.Trends in psychiatry and psychotherapy · 2025Article
- DMT and harmala alkaloids: an exploratory study of oral Acacia based formulations in healthy volunteers.Frontiers in psychiatry · 2025Article
- A new insight into ayahuasca's adverse effects: Reanalysis and perspectives on its mediating role in mental health from the Global Ayahuasca Survey (GAS).PLOS mental health · 2025Article
- Ayahuasca: pharmacology, safety, and therapeutic effects.CNS spectrums · 2024Review
- Neurobiological research on N,N-dimethyltryptamine (DMT) and its potentiation by monoamine oxidase (MAO) inhibition: from ayahuasca to synthetic combinations of DMT and MAO inhibitors.Cellular and molecular life sciences : CMLS · 2024Review
- Ayahuasca-assisted meaning reconstruction therapy for grief: a non-randomized clinical trial protocol.Frontiers in psychiatry · 2024Article
- Why N,N-dimethyltryptamine matters: unique features and therapeutic potential beyond classical psychedelics.Frontiers in psychiatry · 2024Article
- The Psychedelic Future of Post-Traumatic Stress Disorder Treatment.Current neuropharmacology · 2024Review
- Cardiovascular safety of psychedelic medicine: current status and future directions.Pharmacological reports : PR · 2023Review
- Ayahuasca: A review of historical, pharmacological, and therapeutic aspects.PCN reports : psychiatry and clinical neurosciences · 2023Review
- Psilocybin for treatment-resistant depression without psychedelic effects: study protocol for a 4-week, double-blind, proof-of-concept randomised controlled trial.BJPsych open · 2023Article
- A Systematic Review on the Therapeutic Effects of Ayahuasca.Plants (Basel, Switzerland) · 2023Review
- Overcoming the clinical challenges of traditional ayahuasca: a first-in-human trial exploring novel routes of administration of N,N-Dimethyltryptamine and harmine.Frontiers in pharmacology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleAyahuasca is an Amazonian tea containing the natural psychedelic 5-HT(2A/2C/1A) agonist N,N-dimethyltryptamine (DMT). It is used in ceremonial contexts for its visionary properties. The human pharmacology of ayahuasca has been well characterized following its administration in single doses.
objectivesTo evaluate the human pharmacology of ayahuasca in repeated doses and assess the potential occurrence of acute tolerance or sensitization.
methodsIn a double-blind, crossover, placebo-controlled clinical trial, nine experienced psychedelic drug users received PO the two following treatment combinations at least 1 week apart: (a) a lactose placebo and then, 4 h later, an ayahuasca dose; and (b) two ayahuasca doses 4 h apart. All ayahuasca doses were freeze-dried Amazonian-sourced tea encapsulated to a standardized 0.75 mg DMT/kg bodyweight. Subjective, neurophysiological, cardiovascular, autonomic, neuroendocrine, and cell immunity measures were obtained before and at regular time intervals until 12 h after first dose administration.
resultsDMT plasma concentrations, scores in subjective and neurophysiological variables, and serum prolactin and cortisol were significantly higher after two consecutive doses. When effects were standardized by plasma DMT concentrations, no differences were observed for subjective, neurophysiological, autonomic, or immunological effects. However, we observed a trend to reduced systolic blood pressure and heart rate, and a significant decrease for growth hormone (GH) after the second ayahuasca dose.
conclusionsWhereas there was no clear-cut tolerance or sensitization in the psychological sphere or most physiological variables, a trend to lower cardiovascular activation was observed, together with significant tolerance to GH secretion.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.