A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers
5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) is a tryptamine with ultra-rapid onset and short duration of psychedelic effects. Prospective studies for other tryptamines have suggested beneficial effects on mental health outcomes. In preparation for a study in patients with depression, the present st...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2021-11-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2021.760671/full |
| _version_ | 1819043466573774848 |
|---|---|
| author | Johannes Reckweg Natasha L. Mason Cees van Leeuwen Stefan W. Toennes Theis H. Terwey Johannes G. Ramaekers |
| author_facet | Johannes Reckweg Natasha L. Mason Cees van Leeuwen Stefan W. Toennes Theis H. Terwey Johannes G. Ramaekers |
| author_sort | Johannes Reckweg |
| collection | DOAJ |
| description | 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) is a tryptamine with ultra-rapid onset and short duration of psychedelic effects. Prospective studies for other tryptamines have suggested beneficial effects on mental health outcomes. In preparation for a study in patients with depression, the present study GH001-HV-101 aimed to assess the impact of four different dose levels of a novel vaporized 5-MeO-DMT formulation (GH001) administered via inhalation as single doses of 2 (N = 4), 6 (N = 6), 12 (N = 4) and 18 mg (N = 4), and in an individualized dose escalation regimen (N = 4) on the safety, tolerability, and the dose-related psychoactive effects in healthy volunteers (N = 22). The psychedelic experience was assessed with a novel Peak Experience Scale (PES), the Mystical Experience Questionnaire (MEQ), the Ego Dissolution Inventory (EDI), the Challenging Experience Questionnaire (CEQ), and the 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). Further aims were to assess the impact of 5-MeO-DMT on cognitive functioning, mood, and well-being. Higher doses of 5-MeO-DMT produced significant increments in the intensity of the psychedelic experience ratings as compared to the lowest 2 mg dose on all questionnaires, except the CEQ. Prominent effects were observed following single doses of 6, 12, and 18 mg on PES and MEQ ratings, while maximal effects on PES, MEQ, EDI, and 5D-ASC ratings were observed following individualized dose escalation of 5-MeO-DMT. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Vital signs at 1 and 3 h after administration were not affected and adverse events were generally mild and resolved spontaneously. Individualized dose escalation of 5-MeO-DMT may be preferable over single dose administration for clinical applications that aim to maximize the experience to elicit a strong therapeutic response. |
| first_indexed | 2024-12-21T09:57:14Z |
| format | Article |
| id | doaj.art-e184c8d6ff2d4874a02b13c224376a5e |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-21T09:57:14Z |
| publishDate | 2021-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-e184c8d6ff2d4874a02b13c224376a5e2022-12-21T19:08:02ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122021-11-011210.3389/fphar.2021.760671760671A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy VolunteersJohannes Reckweg0Natasha L. Mason1Cees van Leeuwen2Stefan W. Toennes3Theis H. Terwey4Johannes G. Ramaekers5Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, NetherlandsFaculty of Psychology and Neuroscience, Maastricht University, Maastricht, NetherlandsFaculty of Psychology and Neuroscience, Maastricht University, Maastricht, NetherlandsInstitute of Legal Medicine, University of Frankfurt, Frankfurt, GermanyGH Research, Dublin, IrelandFaculty of Psychology and Neuroscience, Maastricht University, Maastricht, Netherlands5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) is a tryptamine with ultra-rapid onset and short duration of psychedelic effects. Prospective studies for other tryptamines have suggested beneficial effects on mental health outcomes. In preparation for a study in patients with depression, the present study GH001-HV-101 aimed to assess the impact of four different dose levels of a novel vaporized 5-MeO-DMT formulation (GH001) administered via inhalation as single doses of 2 (N = 4), 6 (N = 6), 12 (N = 4) and 18 mg (N = 4), and in an individualized dose escalation regimen (N = 4) on the safety, tolerability, and the dose-related psychoactive effects in healthy volunteers (N = 22). The psychedelic experience was assessed with a novel Peak Experience Scale (PES), the Mystical Experience Questionnaire (MEQ), the Ego Dissolution Inventory (EDI), the Challenging Experience Questionnaire (CEQ), and the 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). Further aims were to assess the impact of 5-MeO-DMT on cognitive functioning, mood, and well-being. Higher doses of 5-MeO-DMT produced significant increments in the intensity of the psychedelic experience ratings as compared to the lowest 2 mg dose on all questionnaires, except the CEQ. Prominent effects were observed following single doses of 6, 12, and 18 mg on PES and MEQ ratings, while maximal effects on PES, MEQ, EDI, and 5D-ASC ratings were observed following individualized dose escalation of 5-MeO-DMT. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Vital signs at 1 and 3 h after administration were not affected and adverse events were generally mild and resolved spontaneously. Individualized dose escalation of 5-MeO-DMT may be preferable over single dose administration for clinical applications that aim to maximize the experience to elicit a strong therapeutic response.https://www.frontiersin.org/articles/10.3389/fphar.2021.760671/full5-MeO-DMTpsychedelic agentspsychoactivecognitiondose finding |
| spellingShingle | Johannes Reckweg Natasha L. Mason Cees van Leeuwen Stefan W. Toennes Theis H. Terwey Johannes G. Ramaekers A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers Frontiers in Pharmacology 5-MeO-DMT psychedelic agents psychoactive cognition dose finding |
| title | A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers |
| title_full | A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers |
| title_fullStr | A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers |
| title_full_unstemmed | A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers |
| title_short | A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers |
| title_sort | phase 1 dose ranging study to assess safety and psychoactive effects of a vaporized 5 methoxy n n dimethyltryptamine formulation gh001 in healthy volunteers |
| topic | 5-MeO-DMT psychedelic agents psychoactive cognition dose finding |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2021.760671/full |
| work_keys_str_mv | AT johannesreckweg aphase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT natashalmason aphase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT ceesvanleeuwen aphase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT stefanwtoennes aphase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT theishterwey aphase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT johannesgramaekers aphase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT johannesreckweg phase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT natashalmason phase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT ceesvanleeuwen phase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT stefanwtoennes phase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT theishterwey phase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers AT johannesgramaekers phase1doserangingstudytoassesssafetyandpsychoactiveeffectsofavaporized5methoxynndimethyltryptamineformulationgh001inhealthyvolunteers |