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Cited by 58Psychedelics and Drug StudiesParanormal Experiences and BeliefsForensic Toxicology and Drug Analysis

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

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Reckweg, Johannes, Mason, Natasha L., van Leeuwen, Cees, Toennes, Stefan W., Terwey, Theis H., Ramaekers, Johannes G.·2021·Frontiers in Pharmacology
DOI 10.3389/fphar.2021.760671PMC PMC8667866
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Abstract

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.

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  • In the 2 identified studies of 5-MeO-DMT, no SAEs or NSAEs of medical or psychiatric significance were reported.

    “In the 2 identified studies of 5-MeO-DMT, 1 in healthy participants (n = 22)18 and the other among participants with treatment-resistant depression (n = 16),19 no SAEs or NSAEs of medical or psychiatric significance were reported.”

    From Adverse Events in Studies of Classic Psychedelics: A Systematic Review and Meta-Analysis (2024) · cites this paper as [18]

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Authors
Reckweg, J., Mason, N. L., van Leeuwen, C., Toennes, S. W., Terwey, T. H., & Ramaekers, J. G.
Affiliations
  • Maastricht University (NL)
  • Goethe University Frankfurt (DE)
Corresponding author
Ramaekers, Johannes G.
ORCID
Venue
Frontiers in Pharmacology
Publisher
Frontiers Media SA
Published
2021-11-25
Volume
12
Pages
760671-760671
ISSN
1663-9812 (ISSN-L)
DOI
10.3389/fphar.2021.760671
PMC
PMC8667866
OpenAlex
W3215098003
Cited by
58
References
16
Citations by year
2026: 11 · 2025: 15 · 2024: 14 · 2023: 12 · 2022: 6
FWCI
5.42
Type
journal article
Language
en
Open access
Licence
Locations
  • Frontiers in Pharmacology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research Publications (Maastricht University) (submittedVersion, cc-by)
  • Research Publications (Maastricht University) (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Social Sciences › Psychology › Social Psychology › Paranormal Experiences and Beliefs
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
Keywords
5-MeO-DMT, psychedelic experience, dose escalation, peak experiences, mystical experience, ego dissolution, altered states of consciousness, cognitive function, mood, well-being, safety and tolerability, depression

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