An Early Phase 1 interventional study of DMT + harmine and Placebo in Healthy Participants, sponsored by Milan Scheidegger. Completed at 1 site in Switzerland. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Milan Scheidegger · Early Phase 1, Interventional, and Basic science
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.
This is the only study on the registry with Milan Scheidegger as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm comprises the following interventions: * Mindfulness Intervention in the course of the meditation group retreat * Administration of DMT + harmine (moderate-high dose)
Drug: DMT + harmine
This arm comprises the following interventions: * Mindfulness Intervention in the course of the meditation group retreat * Administration of Placebo
Drug: Placebo
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.
Functional brain connectivity changes in response to DMT-enhanced mindfulness in experienced meditators (rs-fMRI)
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: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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: Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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: Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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: Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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: Follow-up 1 month after the group meditation retreat
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Connectedness: Watts Connectedness Scale (visual analog scale; minimum value = 0; maximum value = 100)
Time frame: Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Mindfulness: Freiburg Mindfulness Inventory (minimum value = 1; maximum value = 4; higher scores indicate greater mindfulness)
Time frame: Baseline - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Gratitude: Gratitude Questionnaire (minimum value = 1; maximum value = 7)
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
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Psychological Insights: Psychological Insight Scale (visual analog scale: left = not more than before; right = very much more than before)
Time frame: Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Psychological Flexibility: Psy-Flex Questionnaire (minimum value = 1; maximum value = 5; higher scores indicate greater psychological flexibility)
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
Phenomenological reports in response to DMT-enhanced mindfulness in experienced meditators
Microphenomenological and semi-structured qualitative interviews
Time frame: Within 24 hours after drug administration - Follow-up 1 month after the group meditation retreat
Incidence of Treatment-Emergent Adverse Events
Frequency of occurence of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: On study days with pharmacological intervention (at baseline, 30, 60, 90, 120, 180, 240, and 360 min after drug administration)
EmpaToM (fMRI task)
The EmpaToM is a validated fMRI test paradigm to assess emotional valence, compassion or empathy and theory of mind
Time frame: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
Mediating Variables
Personality Type: Ten-Item Personality Inventory (minimal value =1; maximal value = 7)
Time frame: Baseline - Study Day with pharmacological intervention - 1 day after group meditation retreat - Follow-up 1 week after the group meditation retreat
Mediating Variables
Personality Type: Affective Neuroscience Personality Scale (minimum value = 1; maximum value = 4)
Time frame: Baseline
Mediating Variables
Meditation Motivation (single-choice) \& Intention (visual analog scale)
Time frame: Baseline - Study Day with pharmacological intervention - Retreat Day 3 - Follow-up 1 week and 1 month after the group meditation retreat
Mediating Variables
Expectations (minimal value = 0; maximal value = 4)
Time frame: Immediately before the pharmacological intervention
Plan to share: No — Only anonymized, quantitative neurophysiological and behavioral data can be shared upon publication according to the FAIR data principles. Qualitative interview data are sensitive and cannot be shared due to confidentiality reasons.
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