Mindfulness and Psychedelics
This double-blind, placebo-controlled trial (n=40) aims to investigate the potential neurophysiological synergy effects between mindfulness meditation and psychedelics, particularly Ayahuasca, on experienced meditators.
Detailed Description
Randomized, double-blind, quadruple-masked, parallel-group study in experienced meditators comparing an oral DMT+h arm with an organoleptically matched placebo during a three-day meditation retreat.
Primary measures include pre- and post- retreat functional MRI to assess network activity and connectivity, psychometric assessments, and detailed experiential interviews to probe neurophenomenology and subjective effects.
Participants are healthy adult meditators (≥1000 hours practice), BMI 18.5–35, randomized to receive a single oral administration of purified DMT plus harmine or placebo during the sitting meditation on day two; neither participants nor investigators are aware of assignment.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
DMT + harmine
experimentalMindfulness retreat + oral DMT and harmine administered during a sitting meditation (day 2).
Interventions
- Ayahuascavia Oral• single dose• 1 doses total
Moderate–high dose of purified DMT + harmine administered during the sitting meditation on day 2 of the retreat.
Placebo
inactiveMindfulness retreat + organoleptically matched placebo administered during a sitting meditation (day 2).
Interventions
- Placebovia Oral• single dose• 1 doses total
Pharmaceutically inactive placebo matched for flavour and appearance.
Participants
Inclusion Criteria
- 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
- 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 Details
- StatusCompleted
- PhasePhase I
- Typeinterventional
- DesignRandomizedquadruple Blind
- Target Enrollment40 participants
- TimelineStart: 2023-02-20End: 2023-09-09
- Compounds
- Topic