Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects
BackgroundThere is growing scientific evidence for the therapeutic benefits of the Amazonian plant-based psychedelic “ayahuasca” for neuropsychiatric disorders such as depression and anxiety. However, there are certain challenges when incorporating botanical ayahuasca into biomedical research and cl...
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Frontiers Media S.A.
2024-01-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1302559/full |
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| author | Helena D. Aicher Helena D. Aicher Helena D. Aicher Michael J. Mueller Michael J. Mueller Michael J. Mueller Dario A. Dornbierer Dario A. Dornbierer Dario A. Dornbierer Dila Suay Dila Suay Claudius Elsner Ilhui Wicki Daniel Meling Daniel Meling Luzia Caflisch Alexandra Hempe Alexandra Hempe Camilla Steinhart Jovin Mueller Robin Von Rotz Birgit Kleim Birgit Kleim Birgit Kleim Milan Scheidegger Milan Scheidegger |
| author_facet | Helena D. Aicher Helena D. Aicher Helena D. Aicher Michael J. Mueller Michael J. Mueller Michael J. Mueller Dario A. Dornbierer Dario A. Dornbierer Dario A. Dornbierer Dila Suay Dila Suay Claudius Elsner Ilhui Wicki Daniel Meling Daniel Meling Luzia Caflisch Alexandra Hempe Alexandra Hempe Camilla Steinhart Jovin Mueller Robin Von Rotz Birgit Kleim Birgit Kleim Birgit Kleim Milan Scheidegger Milan Scheidegger |
| author_sort | Helena D. Aicher |
| collection | DOAJ |
| description | BackgroundThere is growing scientific evidence for the therapeutic benefits of the Amazonian plant-based psychedelic “ayahuasca” for neuropsychiatric disorders such as depression and anxiety. However, there are certain challenges when incorporating botanical ayahuasca into biomedical research and clinical therapy environments. Formulations inspired by ayahuasca, which contain specific and standardized active components, are a potential remedy.MethodsWe investigated subjective acute and persisting effects of a novel formulation containing the reversible monoamine oxidase inhibitor harmine (orodispersible tablet containing 100 mg MAO-I) and N,N-dimethyltryptamine (incremental intranasal dosing of up to 100 mg DMT), compared with two other conditions, namely harmine alone and placebo, in a crossover RCT in 31 healthy male subjects.ResultsDMT + harmine, but not harmine alone, induced a psychedelic experience assessed with the 5D-ASC rating scale [global score: F(2,60) = 80.21, p < 0.001] and acute experience sampling items over time, characterized by psychological insights [PIQ, F(2,58.5) = 28.514, p < 0.001], emotional breakthroughs [EBI, F(2,60) = 26.509, p < 0.001], and low scores on the challenging experience questionnaire [CEQ, F(2,60) = 12.84, p < 0.001]. Participants attributed personal and spiritual significance to the experience (GSR) with mainly positive persisting effects (PEQ) at 1- and 4-months follow-up. Acute drug effects correlated positively with persisting effects. We found no changes in trait measures of personality, psychological flexibility, or general well-being, and no increases in psychopathology (SCL-90-R) were reported.Discussion and ConclusionOur results suggest that the experience induced by the standardized DMT + harmine formulation induces a phenomenologically rich psychedelic experience, demonstrates good psychological safety and tolerability, is well tolerated, and induces beneficial psychological processes that could possibly support psychotherapy. Further studies are required to investigate the psychotherapeutic potential in patients. |
| first_indexed | 2024-03-08T15:45:24Z |
| format | Article |
| id | doaj.art-fbee90a9fd9245d2bd6bf8e1dc38067e |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-03-08T15:45:24Z |
| publishDate | 2024-01-01 |
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| series | Frontiers in Psychiatry |
| spelling | doaj.art-fbee90a9fd9245d2bd6bf8e1dc38067e2024-01-09T13:07:01ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402024-01-011410.3389/fpsyt.2023.13025591302559Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjectsHelena D. Aicher0Helena D. Aicher1Helena D. Aicher2Michael J. Mueller3Michael J. Mueller4Michael J. Mueller5Dario A. Dornbierer6Dario A. Dornbierer7Dario A. Dornbierer8Dila Suay9Dila Suay10Claudius Elsner11Ilhui Wicki12Daniel Meling13Daniel Meling14Luzia Caflisch15Alexandra Hempe16Alexandra Hempe17Camilla Steinhart18Jovin Mueller19Robin Von Rotz20Birgit Kleim21Birgit Kleim22Birgit Kleim23Milan Scheidegger24Milan Scheidegger25Psychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Psychology, University of Zurich, Zurich, SwitzerlandNeuroscience Center Zurich, University of Zurich and ETH, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandNeuroscience Center Zurich, University of Zurich and ETH, Zurich, SwitzerlandDepartment of Health Science and Technology, ETH, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandInstitute of Pharmacology and Toxicology, University of Zurich, Zurich, SwitzerlandDepartment of Forensic Pharmacology and Toxicology, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandMoMiLab, IMT School for Advanced Studies Luca, Lucca, ItalyPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Psychosomatic Medicine and Psychotherapy, Medical Center–University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, GermanyPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandBiopsychology, Department of Psychology, TUD Dresden University of Technology, Dresden, GermanyPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Psychology, University of Zurich, Zurich, SwitzerlandNeuroscience Center Zurich, University of Zurich and ETH, Zurich, Switzerland0Experimental Psychopathology and Psychotherapy, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandPsychedelic Research and Therapy Development, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, SwitzerlandNeuroscience Center Zurich, University of Zurich and ETH, Zurich, SwitzerlandBackgroundThere is growing scientific evidence for the therapeutic benefits of the Amazonian plant-based psychedelic “ayahuasca” for neuropsychiatric disorders such as depression and anxiety. However, there are certain challenges when incorporating botanical ayahuasca into biomedical research and clinical therapy environments. Formulations inspired by ayahuasca, which contain specific and standardized active components, are a potential remedy.MethodsWe investigated subjective acute and persisting effects of a novel formulation containing the reversible monoamine oxidase inhibitor harmine (orodispersible tablet containing 100 mg MAO-I) and N,N-dimethyltryptamine (incremental intranasal dosing of up to 100 mg DMT), compared with two other conditions, namely harmine alone and placebo, in a crossover RCT in 31 healthy male subjects.ResultsDMT + harmine, but not harmine alone, induced a psychedelic experience assessed with the 5D-ASC rating scale [global score: F(2,60) = 80.21, p < 0.001] and acute experience sampling items over time, characterized by psychological insights [PIQ, F(2,58.5) = 28.514, p < 0.001], emotional breakthroughs [EBI, F(2,60) = 26.509, p < 0.001], and low scores on the challenging experience questionnaire [CEQ, F(2,60) = 12.84, p < 0.001]. Participants attributed personal and spiritual significance to the experience (GSR) with mainly positive persisting effects (PEQ) at 1- and 4-months follow-up. Acute drug effects correlated positively with persisting effects. We found no changes in trait measures of personality, psychological flexibility, or general well-being, and no increases in psychopathology (SCL-90-R) were reported.Discussion and ConclusionOur results suggest that the experience induced by the standardized DMT + harmine formulation induces a phenomenologically rich psychedelic experience, demonstrates good psychological safety and tolerability, is well tolerated, and induces beneficial psychological processes that could possibly support psychotherapy. Further studies are required to investigate the psychotherapeutic potential in patients.https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1302559/fullayahuascaayahuasca analogDMTharminetherapeutic potentialpsychological processes |
| spellingShingle | Helena D. Aicher Helena D. Aicher Helena D. Aicher Michael J. Mueller Michael J. Mueller Michael J. Mueller Dario A. Dornbierer Dario A. Dornbierer Dario A. Dornbierer Dila Suay Dila Suay Claudius Elsner Ilhui Wicki Daniel Meling Daniel Meling Luzia Caflisch Alexandra Hempe Alexandra Hempe Camilla Steinhart Jovin Mueller Robin Von Rotz Birgit Kleim Birgit Kleim Birgit Kleim Milan Scheidegger Milan Scheidegger Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects Frontiers in Psychiatry ayahuasca ayahuasca analog DMT harmine therapeutic potential psychological processes |
| title | Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects |
| title_full | Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects |
| title_fullStr | Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects |
| title_full_unstemmed | Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects |
| title_short | Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects |
| title_sort | potential therapeutic effects of an ayahuasca inspired n n dmt and harmine formulation a controlled trial in healthy subjects |
| topic | ayahuasca ayahuasca analog DMT harmine therapeutic potential psychological processes |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1302559/full |
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