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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

Published online by Cambridge University Press:  01 September 2022

J. Reckweg ,
N. Mason ,
C. Van Leeuwen ,
S. Tönnes ,
T. Terwey  and
J. Ramaekers
J. Reckweg*
Affiliation:
Maastricht University, Faculty Of Psychology And Neuroscience, Department Of Neuropsychology And Psychopharmacology, Maastricht, Netherlands
N. Mason
Affiliation:
Maastricht University, Faculty Of Psychology And Neuroscience, Department Of Neuropsychology And Psychopharmacology, Maastricht, Netherlands
C. Van Leeuwen
Affiliation:
Maastricht University, Faculty Of Psychology And Neuroscience, Department Of Neuropsychology And Psychopharmacology, Maastricht, Netherlands
S. Tönnes
Affiliation:
Goethe-Universität Frankfurt am Main, Institut Für Rechtsmedizin, Frankfurt am Main, Germany
T. Terwey
Affiliation:
GH Research PLC, Chief Executive Officer, Dublin, Ireland
J. Ramaekers
Affiliation:
Maastricht University, Faculty Of Psychology And Neuroscience, Department Of Neuropsychology And Psychopharmacology, Maastricht, Netherlands
*
*Corresponding author.

Abstract

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Introduction

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.

Objectives

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, and in an individualized dose escalation regimen on the safety, tolerability, and the dose-related psychoactive effects in healthy volunteers (n=22). Further, we aimed to assess the impact on cognitive functioning, mood, and well-being.

Methods

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).

Results

5-MeO-DMT produced dose-related increments in the intensity of the psychedelic experience ratings 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. Vital signs at 1 and 3 h after administration were not affected and adverse events were generally mild and resolved spontaneously.

Conclusions

Individualized dose escalation of 5-MeO-DMT may be preferable over single dose administration for clinical applications that aim to enhance the short-term psychoactive effects to elicit a strong therapeutic response.

Disclosure

This study was funded by GH Research PLC, Dublin, Ireland.

Keywords

GH0015-MeO-DMTPhase 1Safety
Type
Abstract
Information
European Psychiatry , Volume 65 , Special Issue S1: Abstracts of the 30th European Congress of Psychiatry , June 2022 , pp. S716
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2022. Published by Cambridge University Press on behalf of the European Psychiatric Association
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