Psychiatric University Hospital Zurich
Zurich, 8032, Switzerland
NCT Number: NCT05780216
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.
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Notify Me25 year–60 year
All sexes
Interventional
Early Phase 1
Zurich, 8032, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The placebo consists of pharmaceutically inactive ingredients and additional flavors, and is organoleptically hardly distinguishable from the verum.
Time frame: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
The primary endpoint of this present study is to test functional brain connectivity at rest and during meditation in response to DMT-enhanced mindfulness in experienced meditators. More specifically, the present study aims at assessing the impact of DMT-enhanced mindfulness on the attenuation of Default Mode Network (DMN) activity and connectivity with fMRI recordings before and after a group meditation retreat using SVA and ICA analyses.
Time frame: Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Measures of drug-induced altered states of consciousness:
Mystical Experience Questionnaire (minimum value = 0; maximum value = 5; higher scores indicate individual mystical experiences)
Time frame: Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Measures of drug-induced altered states of consciousness:
Visual Self-Transcendence Scale (minimum value = 1; maximum value = 7; higher scores indicate higher self-transcendence)
Time frame: Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Measures of drug-induced altered states of consciousness:
Non-dual Awareness Dimensional Assessment Scale-State (visual analog scale; minimum value = 0; maximum value = 10)
Time frame: Follow-up 1 month after the group meditation retreat
Measures of drug-induced altered states of consciousness:
Persisting Effects Questionnaire (minimum value = no change [1]; maximum value = very strong change [5]; higher scores indicate greater change)
Time frame: Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
Mindfulness & Compassion:
Toronto Mindfulness Scale (minimum value = 0; maximum value = 4; higher scores indicate greater mindfulness) Meditation Depth Questionnaire (minimum value = 0; maximum value = 4) Sussex-Oxford Compassion Scale (minimum value = 0; maximum value = 4)
Time frame: Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
Connectedness:
Watts Connectedness Scale (visual analog scale; minimum value = 0; maximum value = 100)
Time frame: Baseline - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
Mindfulness:
Freiburg Mindfulness Inventory (minimum value = 1; maximum value = 4; higher scores indicate greater mindfulness)
Time frame: Baseline - Study Day with pharmacological intervention - Retreat Day 3 - 1 day after the group meditation retreat - Follow-up 1 week after the group meditation retreat
Gratitude:
Gratitude Questionnaire (minimum value = 1; maximum value = 7)
Time frame: Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Psychological Insights:
Psychological Insight Scale (visual analog scale: left = not more than before; right = very much more than before)
Time frame: 1 day before the group meditation retreat -1 day after the group meditation retreat - Follow-up 1 week after the group meditation retreat
Psychological Flexibility:
Psy-Flex Questionnaire (minimum value = 1; maximum value = 5; higher scores indicate greater psychological flexibility)
Time frame: Within 24 hours after drug administration - Follow-up 1 month after the group meditation retreat
Microphenomenological and semi-structured qualitative interviews
Time frame: On study days with pharmacological intervention (at baseline, 30, 60, 90, 120, 180, 240, and 360 min after drug administration)
Frequency of occurence of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
The EmpaToM is a validated fMRI test paradigm to assess emotional valence, compassion or empathy and theory of mind
Time frame: Baseline - Study Day with pharmacological intervention - 1 day after group meditation retreat - Follow-up 1 week after the group meditation retreat
Personality Type:
Ten-Item Personality Inventory (minimal value =1; maximal value = 7)
Time frame: Baseline
Personality Type:
Affective Neuroscience Personality Scale (minimum value = 1; maximum value = 4)
Time frame: Baseline - Study Day with pharmacological intervention - Retreat Day 3 - Follow-up 1 week and 1 month after the group meditation retreat
Meditation Motivation (single-choice) & Intention (visual analog scale)
Time frame: Immediately before the pharmacological intervention
Expectations (minimal value = 0; maximal value = 4)
Milan Scheidegger
Other
Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators
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