Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects

This crossover RCT (n=31) investigates the effects of a novel ayahuasca-inspired formulation containing harmine and DMT in healthy male subjects. It finds that the combination of DMT and harmine, but not harmine alone, leads to a psychedelic experience with psychological insights, emotional breakthroughs, and low challenging experiences. The study reports positive persisting effects at 1- and 4-month follow-ups, with no changes in personality traits, psychological flexibility, general well-being, or increases in psychopathology.

Abstract of Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation

Background: There 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.

Methods: We 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.

Results: DMT + 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 Conclusion: Our 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.”

Authors: Helena D. Aicher, Michael J. Mueller, Dario A. Dornbierer, Dila Suay, Claudius Elsner, Ilhui Wicki, Daniel Meling, Luzia Caflisch, Alexandra Hempe, Camilla Steinhart, Jovin Mueller, Robin Von Rotz, Birgit Kleim & Milan Scheidegger

Summary of Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation

Scientific interest in the Amazonian psychedelic ayahuasca has increased due to its potential therapeutic benefits and its increasingly globalized use. Ayahuasca contains the vine Banisteriopsis caapi and other ingredients such as Psychotria viridis or Diplopterys cabrerana.

Orally ingested DMT in ayahuasca preparations induces psychedelic effects, including alterations in the perception of the self and the world, changes in mood and cognition, visionary experiences and bodily sensations.

Ayahuasca induces transient introspective states characterized by increased awareness, introspection and self-reflection, dream-like visions, recollection of personal memories, and intensified emotions. These states might promote the efficacy of psychotherapeutic interventions by promoting the understanding of one’s potentially maladaptive but also goal-oriented relational, behavioural, and cognitive patterns.

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Find this paper

Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects

https://doi.org/10.3389/fpsyt.2023.1302559

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Cite this paper (APA)

Aicher, H. D., Mueller, M. J., Dornbierer, D. A., Suay, D., Elsner, C., Wicki, I., ... & Scheidegger, M. Potential Therapeutic Effects of an Ayahuasca-inspired N, N-DMT and Harmine Formulation: A Controlled Trial in Healthy Subjects. Frontiers in Psychiatry14, 1302559.

Study details

Compounds studied
Ayahuasca

Topics studied
Healthy Subjects

Study characteristics
Original Placebo-Controlled Double-Blind Within-Subject Randomized

Participants
31 Humans

Institutes

Institutes associated with this publication

University of Zurich
Within the Department of Psychiatry, Psychotherapy and Psychosomatics at the University of Zurich, Dr Mialn Scheidegger is leading team conducting psychedelic research and therapy development.

Compound Details

The psychedelics given at which dose and how many times

DMT 100 mg | 1x

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