{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T23:07:45Z","timestamp":1788476865108,"version":"build-2803163510"},"reference-count":52,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T00:00:00Z","timestamp":1736294400000},"content-version":"vor","delay-in-days":11,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Fabian Hediger"},{"name":"SNSF Swiss National Science Foundation","award":["P0ZHP1_191935"],"award-info":[{"award-number":["P0ZHP1_191935"]}]},{"name":"SNSF Swiss National Science Foundation","award":["CRSK-1_196833"],"award-info":[{"award-number":["CRSK-1_196833"]}]},{"name":"SNSF Swiss National Science Foundation","award":["40B1-0_198689"],"award-info":[{"award-number":["40B1-0_198689"]}]},{"name":"Bioentrepreneur Fellowship UZH","award":["BIOEF-18-009"],"award-info":[{"award-number":["BIOEF-18-009"]}]},{"name":"Forschungskredit PostDoc UZH","award":["FK-18-052"],"award-info":[{"award-number":["FK-18-052"]}]},{"name":"BIAL Foundation","award":["333\/20"],"award-info":[{"award-number":["333\/20"]}]},{"name":"Reconnect Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Recent interest in the clinical use of psychedelics has highlighted plant-derived medicines like ayahuasca showing rapid-acting and sustainable therapeutic effects in various psychiatric conditions. This traditional Amazonian plant decoction contains N,N-dimethyltryptamine (DMT) and \u03b2-carboline alkaloids such as harmine. However, its use is often accompanied by distressing effects like nausea, vomiting, and intense hallucinations, possibly due to complex pharmacokinetic\/pharmacodynamic (PK-PD) interactions and lack of dose standardization.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This study addresses these limitations by testing a novel pharmaceutical formulation containing pure forms of DMT and harmine in a double-blind, randomized, placebo-controlled trial with 31 healthy male volunteers. We evaluated PK-PD by monitoring drug and metabolite plasma levels, subjective effects, adverse events, and cardiovascular parameters. Each participant received 3 randomized treatments: (1) 100\u00a0mg buccal harmine with 100\u00a0mg intranasal DMT, (2) 100\u00a0mg buccal harmine with intranasal placebo, and (3) full placebo, using a repeated-intermittent dosing scheme, such that 10\u00a0mg of DMT (or placebo) was administered every 15 minutes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>N,N-dimethyltryptamine produced consistent PK profiles with Cmax values of 22.1\u00a0ng\/mL and acute drug effects resembling the psychological effects of ayahuasca with a duration of 2\u20133 hours. Likewise, buccal harmine produced sustained-release PK profiles with Cmax values of 32.5\u00a0ng\/mL but lacked distinguishable subjective effects compared to placebo. All drug conditions were safe and well tolerated, indicating the formulation\u2019s suitability for clinical applications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study underscores the potential of a patient-oriented pharmaceutical formulation of DMT and harmine to reduce risks and improve therapeutic outcomes in treating mental health disorders.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial registration number<\/jats:title>\n                  <jats:p>Neurodynamics of prosocial emotional processing following serotonergic stimulation with N,N-dimethyltryptamine (DMT) and harmine in healthy subjects (NCT04716335) https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04716335<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ijnp\/pyaf001","type":"journal-article","created":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T05:01:34Z","timestamp":1736312494000},"source":"Crossref","is-referenced-by-count":11,"title":["Pharmacokinetics and pharmacodynamics of an innovative psychedelic N,N-dimethyltryptamine\/harmine formulation in healthy participants: a randomized controlled trial"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9774-9805","authenticated-orcid":false,"given":"Michael J","family":"Mueller","sequence":"first","affiliation":[{"name":"Department of Adult Psychiatry and Psychotherapy, Psychiatric University Clinic Zurich and University of Zurich , Zurich,","place":["Switzerland"]},{"name":"Department of Health Science & Technology, ETH Zurich , Zurich,","place":["Switzerland"]},{"name":"Neuroscience Center Zurich, University of Zurich and Swiss Federal Institute of Technology Zurich , 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