Healthy ParticipantsEarly Phase 1NCT05780216
Mindfulness and Psychedelics
A Early Phase 1 study testing DMT + harmine in people with Healthy Participants, run by Milan Scheidegger at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- DMT + harmine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Feb 2023to 15 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators
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.
- Conditions
- Healthy Participants
- Being tested
- DMT + harmine, Placebo
- Keywords
- DMT, harmine, pharmahuasca, ayahuasca, healthy participants, meditation, group retreat, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMT + harmineDrug
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.
PlaceboDrug
The placebo consists of pharmaceutically inactive ingredients and additional flavors, and is organoleptically hardly distinguishable from the verum.
| Study group | Role | What they receive |
|---|---|---|
| DMT and harmine | Experimental | This arm comprises the following interventions:
* Mindfulness Intervention in the course of the meditation group retreat
* Administration of DMT + harmine (moderate-high dose) Receives: Drug: DMT + harmine |
| Placebo | Placebo comparator | This arm comprises the following interventions:
* Mindfulness Intervention in the course of the meditation group retreat
* Administration of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
Secondary outcomes (17)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline
Mediating Variables
Meditation Motivation (single-choice) \& Intention (visual analog scale)
Measured: 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)
Measured: Immediately before the pharmacological intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start20 Feb 2023
- Primary completion5 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled, between-subjects study design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milan Scheidegger
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Freiburg
- Responsible party
- Sponsor-investigator, Milan Scheidegger, Psychiatric University Hospital, Zurich
- Investigators
- Milan Scheidegger, MD, PhD, Principal investigator, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780216
- Sponsor's protocol ID
- DMT-HAR-MED
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Meling D, Egger K, Aicher HD, Jareno Redondo J, Mueller J, Dornbierer J, Temperli E, Vasella EA, Caflisch L, Pfeiffer DJ, Schlomberg JT, Smallridge JW, Dornbierer DA, Scheidegger M. Meditating on psychedelics. A randomized placebo-controlled study of DMT and harmine in a mindfulness retreat. J Psychopharmacol. 2024 Oct;38(10):897-910. doi: 10.1177/02698811241282637. Epub 2024 Sep 27.
PubMed 39340164
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators
- ClinicalTrials.gov ID
- NCT05780216
- Acronym / sponsor ID
- DMT-HAR-MED
- Conditions
- Healthy Participants
- Keywords
- DMT, harmine, pharmahuasca, ayahuasca, healthy participants, meditation, group retreat, mindfulness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Milan ScheideggerUniversity, hospital or other
- Collaborators
- University Medical Center Freiburg
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled, between-subjects study design
| Arm | Type | Receives |
|---|---|---|
| DMT and harmine | Experimental | Drug: DMT + harmineThis arm comprises the following interventions: * Mindfulness Intervention in the course of the meditation group retreat * Administration of DMT + harmine (moderate-high dose) |
| Placebo | Placebo comparator | Drug: PlaceboThis arm comprises the following interventions: * Mindfulness Intervention in the course of the meditation group retreat * Administration of Placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMT + harmineThe intervention used in this study is a combination of the two main ingredients of ayahuasca, DMT (N,N-dimethyltryptamine) and harmine in purified form. | Drug | DMT and harmine |
| PlaceboThe placebo consists of pharmaceutically inactive ingredients and additional flavors, and is organoleptically hardly distinguishable from the verum. | Drug | Placebo |
Primary outcome
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
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.
17 secondary outcomes
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
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
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
Psychometric changes in response to DMT-enhanced mindfulness in experienced meditators
Time frame: Follow-up 1 month after the group meditation retreat
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
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
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
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
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
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
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
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)
EmpaToM (fMRI task)
Time frame: fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat
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
Mediating Variables
Time frame: Baseline
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
Mediating Variables
Time frame: Immediately before the pharmacological intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 39340164Meling D, Egger K, Aicher HD, Jareno Redondo J, Mueller J, Dornbierer J, Temperli E, Vasella EA, Caflisch L, Pfeiffer DJ, Schlomberg JT, Smallridge JW, Dornbierer DA, Scheidegger M. Meditating on psychedelics. A randomized placebo-controlled study of DMT and harmine in a mindfulness retreat. J Psychopharmacol. 2024 Oct;38(10):897-910. doi: 10.1177/02698811241282637. Epub 2024 Sep 27.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Scheidegger, MD, PhD principal investigator
Psychiatric University Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DMT + harmine in people with Healthy Participants, run by Milan Scheidegger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.