- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780216
Mindfulness and Psychedelics
Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Milan Scheidegger, MD, PhD
- Phone Number: +41 79 436 13 92
- Email: milan.scheidegger@bli.uzh.ch
Study Locations
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-
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Zurich, Switzerland, 8032
- Psychiatric University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- Not more than little experience with psychedelic substances
- Experience in Buddhist meditation: participants have a minimum of 1000 hours of lifetime formal meditation practice, e.g. Mahayana (Zen) Theravada (Vipassana) Buddhism or Mahamudra/Dzogchen as primary meditation background, familiarity with longer periods of meditation in a retreat setting.
- Body mass index (BMI) between 18.5 and 35
- Willing to refrain from drinking alcohol during the retreat and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
- Able and willing to comply with all study requirements
- Informed consent form was signed
- Good knowledge of the German language
- Participant informs study physicians / project scientists about simultaneous treatment or therapy with other physicians and about current intake of psychotropic substances or medication
- Women of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Exclusion Criteria:
- Previous significant adverse response to a hallucinogenic drug or to a mindfulness intervention (e.g. meditation retreat)
- Participation in another study where pharmaceutical compounds will be given
- Presence of Axis I affective, anxiety, or dissociative disorders
- Present or antecedent diagnosis of bipolar disorder (I, II, not otherwise specified), schizophrenia, schizoaffective disorder, psychosis, or other disorders from the psychotic spectrum
- First-degree relatives with present or antecedent schizophrenia, schizoaffective disorder, or bipolar disorder type I
- History of head trauma, seizures, cancer, or cerebrovascular accidents
- Recent cardiac or brain surgery
- Current abuse of medication or psychotropic substances (including nicotine addiction) according to SCID I criteria
- Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
- Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction, coronary spastic angina)
- Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
- Cerebrovascular disease (e.g. stroke, intracranial bleeding / hemorrhage, intracranial aneurysm)
- Serious abnormalities in ECG or blood count/chemistry
- Liver or renal or pulmonary disease
- Pregnant or breastfeeding women (a urine pregnancy test will be done for all women capable of bearing children)
- Inability to lie still for about 60 minutes (e.g. because of sneezing, itching, tremor, pain)
- Left-handedness
- MRI-exclusion criteria: Metal parts in the body (piercings, brain aneurysm clip, implanted neural stimulator/cardiac pacemaker/defibrillator/Swan Ganz catheter/insulin pump, cochlear implant); metal shrapnel or bullet, ocular foreign body (e.g. metal shavings); current or previous job in metalworking industry
- Claustrophobia
- Current use of medications with significant interaction potential with MAOI (e.g. antidepressants, antipsychotics, psychostimulants, dopaminergic/serotonergic agents, anticonvulsants);
- high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g. evidence of serious personality disorder, serious current stressors, lack of social support).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DMT and harmine
This arm comprises the following interventions:
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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.
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Placebo Comparator: Placebo
This arm comprises the following interventions:
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The placebo consists of pharmaceutically inactive ingredients and additional flavors, and is organoleptically hardly distinguishable from the verum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional brain connectivity changes in response to DMT-enhanced mindfulness in experienced meditators (rs-fMRI)
Time Frame: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
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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.
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fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phenomenological reports in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Within 24 hours after drug administration - Follow-up 1 month after the group meditation retreat
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Microphenomenological and semi-structured qualitative interviews
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Within 24 hours after drug administration - Follow-up 1 month after the group meditation retreat
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Incidence of Treatment-Emergent Adverse Events
Time Frame: On study days with pharmacological intervention (at baseline, 30, 60, 90, 120, 180, 240, and 360 min after drug administration)
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Frequency of occurence of treatment-related adverse events as assessed by CTCAE v5.0
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On study days with pharmacological intervention (at baseline, 30, 60, 90, 120, 180, 240, and 360 min after drug administration)
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EmpaToM (fMRI task)
Time Frame: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
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The EmpaToM is a validated fMRI test paradigm to assess emotional valence, compassion or empathy and theory of mind
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fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Measures of drug-induced altered states of consciousness: Mystical Experience Questionnaire (minimum value = 0; maximum value = 5; higher scores indicate individual mystical experiences) |
Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Measures of drug-induced altered states of consciousness: Visual Self-Transcendence Scale (minimum value = 1; maximum value = 7; higher scores indicate higher self-transcendence) |
Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Measures of drug-induced altered states of consciousness: Non-dual Awareness Dimensional Assessment Scale-State (visual analog scale; minimum value = 0; maximum value = 10) |
Baseline - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Follow-up 1 month after the group meditation retreat
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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) |
Follow-up 1 month after the group meditation retreat
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
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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) |
Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
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Connectedness: Watts Connectedness Scale (visual analog scale; minimum value = 0; maximum value = 100) |
Baseline - Study Day with pharmacological intervention - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Baseline - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
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Mindfulness: Freiburg Mindfulness Inventory (minimum value = 1; maximum value = 4; higher scores indicate greater mindfulness) |
Baseline - 1 day after the group retreat - Follow-up 1 week after the group meditation retreat
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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
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Gratitude: Gratitude Questionnaire (minimum value = 1; maximum value = 7) |
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
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time Frame: Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Psychological Insights: Psychological Insight Scale (visual analog scale: left = not more than before; right = very much more than before) |
Retreat Day 1 - Retreat Day 2 (i.e. study day with pharmacological intervention) - Retreat Day 3
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Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
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
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Psychological Flexibility: Psy-Flex Questionnaire (minimum value = 1; maximum value = 5; higher scores indicate greater psychological flexibility) |
1 day before the group meditation retreat -1 day after the group meditation retreat - Follow-up 1 week after the group meditation retreat
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Mediating Variables
Time Frame: Baseline - Study Day with pharmacological intervention - 1 day after group meditation retreat - Follow-up 1 week after the group meditation retreat
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Personality Type: Ten-Item Personality Inventory (minimal value =1; maximal value = 7) |
Baseline - Study Day with pharmacological intervention - 1 day after group meditation retreat - Follow-up 1 week after the group meditation retreat
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Mediating Variables
Time Frame: Baseline
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Personality Type: Affective Neuroscience Personality Scale (minimum value = 1; maximum value = 4) |
Baseline
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Mediating Variables
Time Frame: Baseline - Study Day with pharmacological intervention - Retreat Day 3 - Follow-up 1 week and 1 month after the group meditation retreat
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Meditation Motivation (single-choice) & Intention (visual analog scale)
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Baseline - Study Day with pharmacological intervention - Retreat Day 3 - Follow-up 1 week and 1 month after the group meditation retreat
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Mediating Variables
Time Frame: Immediately before the pharmacological intervention
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Expectations (minimal value = 0; maximal value = 4)
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Immediately before the pharmacological intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Milan Scheidegger, MD, PhD, Psychiatric University Hospital, Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMT-HAR-MED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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