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CompletedEarly Phase 1

Mindfulness and Psychedelics

NCT05780216 · Milan Scheidegger

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
40
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Functional brain connectivity changes in response to DMT-enhanced mindfulness in experienced meditators (rs-fMRI)

    Measured over fMRI recordings 1 day before the group meditation retreat - fMRI recordings 1 day after the group meditation retreat

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 60 Years
Ages
All
Sex
Accepted
Healthy volunteers
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).

Where

1 study site

FacilityCityRegionCountry
Psychiatric University Hospital ZurichZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05780216 on ClinicalTrials.gov →

Last updated in the registry 2023-09-21. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits

Substance