Clinical trial NCT05780216: Mindfulness and Psychedelics
Official title: Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators
Conditions: Healthy Participants
Summary: The investigators are doing this project to investigate potential neurophysiological synergy effects between mindfulness meditation and psychedelics. Previous studies have found that both mindfulness and psychedelics like psilocybin modulate neural activity and connectivity of the same brain network. However, little is known about the potential interactions between mindfulness meditation and psychedelics. The indigenous plant preparation "Ayahuasca" is particularly interesting for the combination with mindfulness meditation. It contains two components, N,N-dimethyltryptamine (DMT) and harmine, which are very similar to the body's own messenger substance serotonin and increase its effect in the body. The investigators would now like to find out how these corresponding networks change in experienced meditators after DMT/Harmine-enhanced mindfulness meditation and how this affects their subjective experience. For this functional MRI imaging will be performed, as well as psychometric assessments and detailed experiential interviews before and after a three-day meditation retreat. Participants will be randomly assigned to one of two groups. One group receives DMT and harmine during the sitting meditation on the second day, the other group receives a corresponding placebo. Neither the participants nor the investigator know who will receive a placebo or the combination of DMT/harmine on the day of the experiment. The pre- and post-measurements of the MRI imaging and psychometric questionnaires of the DMT/Harmine group are compared with those of the placebo control group. By examining the synergistic effects of mindfulness meditation and DMT/harmine, the aim of this study is to contribute to a comprehensive understanding of the neurophenomenology of rare and inaccessible phenomena of consciousness.
Interventions:
description: The intervention used in this study is a combination of the two main ingredients of ayahuasca, DMT (N,N-dimethyltryptamine) and harmine in purified form.
name: DMT + harmine
type: Drug
description: The placebo consists of pharmaceutically inactive ingredients and additional flavors, and is organoleptically hardly distinguishable from the verum.
name: Placebo
type: Drug
Study arms:
design_group_description: This arm comprises the following interventions:<br/>* Mindfulness Intervention in the course of the meditation group retreat<br/>* Administration of DMT + harmine (moderate-high dose)
design_group_title: DMT and harmine
design_group_type: Experimental
design_group_description: This arm comprises the following interventions:<br/>* Mindfulness Intervention in the course of the meditation group retreat<br/>* Administration of Placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Psychiatric Hospital of The University of Zurich
Collaborators: University Medical Center Freiburg
Drug name mappings:
name: 二甲基色胺
lang: CN
name: Dimethyltryptamine
lang: EN
name: 肉叶云香碱
lang: CN
name: Telepathine
lang: EN