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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.

Johannes T. Reckweg, Natasha L. Mason, Cees van Leeuwen, Stefan W. Toennes, Theis H Terwey, Johannes G. Ramaekers

Frontiers in Pharmacology 2021 DOI: 10.3389/fphar.2021.760671 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Prospective dose-finding study Peer reviewed
Sample size 22
Population Healthy volunteers
Intervention individualized dose escalation regimen
Dose 2, 6, 12, and 18 mg single doses; individualized dose escalation
Topics 5-MeO-DMT DMT
Keywords Cognition Dose finding Psychedelic agents Psychoactive
Citations 58
Data Figshare
Key points Individualized dose escalation of vaporized 5-MeO-DMT produced maximal psychedelic experience ratings compared to single doses, while cognition, mood, and well-being were unaffected.

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.

Comparable studies

Other observational and cohort studies on 5-MeO-DMT, most cited first.

Study Year Design Participants
A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms. Volunteers who inhaled vapor from dried toad secretion at several European locations 2019 Observational cohort n = 42
Intensity of Mystical Experiences Occasioned by 5-MeO-DMT and Comparison With a Prior Psilocybin Study Individuals at a psychospiritual retreat in Mexico 2018 Observational cohort n = 20
Neural and subjective effects of inhaled N,N-dimethyltryptamine in natural settings. Healthy and experienced participants 2021 Observational field study n = 35
Open-label study of consecutive ibogaine and 5-MeO-DMT assisted-therapy for trauma-exposed male Special Operations Forces Veterans: prospective data from a clinical program in Mexico. Trauma-exposed Special Operations Forces Veterans 2023 Prospective clinical program evaluation n = 86
Exploring 5-MeO-DMT as a pharmacological model for deconstructed consciousness. Participants in naturalistic ceremonial settings who ingested 5-MeO-DMT 2025 Observational study

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5-MeO-DMT DMT Addiction Altered states of consciousness Depression Ego dissolution Mystical experience Mysticism Philosophy of mind