Santo Daime study

Neurometabolites and functional brain connectivity in experienced ayahuasca users of the Santo Daime Church before and after drink the psychedelic ayahuasca brew: an observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21269

Enrollment

Registered

2020-09-04

Start date

2020-09-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Ayahuasca, provided by Santo Daime.

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: ? Must be a member of the Santo Daime church, who volunteers to participate in the research project. ? Must be older than 18 years of age.

Exclusion criteria

Exclusion criteria: ? Medical devices and implants containing metal (e.g. pacemakers, copper birth control spirals, permanent jewelry, aneurysm clips, hearing aids). ? Permanent make-up and other large tattoos. ? Pregnancy or lactation. ? Use of (medicinal) substances in the past 24 hours which can interact with MAO inhibitors, including further MAO inhibitors (tranylcypromine, Parnate, Nardil, Aurorix, etc), all sympathomimetics (including amphetamine, cocaine, methylphenidate, ephedrine, metaraminol, certain asthma agents), certain medicines for cough, cold, hay fever, and allergies that are available without a prescription, such as Otrivin and dextromethorphan-containing agents (Dampo, VapoTab “Vicks”, Darolan and others) and antihistamines, diet medication (such as Ponderal), all antidepressants including SSRIs (citalopram, sertraline, etc) and trycyclic antidepresssents (clomipramine, etc), certain anti-asthma medications such as Berotec, Bricanyl, Ventolin, Salbutamol, Terbutaline, Pulmadil, or Serevent, blood pressure medication (beta blockers, methyldopa, thiazide diuretics, calcium antagonists, and ace inhibitors), antimicrobials or antibiotics, narcotic analgesices (including pethidine), or other substances like St. John’s wort, lithium, alprazolam, buspirone, L-tryptophan, L-DOPA, disulfiram, hydralazine (such as Apresoline), and carbamazepine (such as Tegretol). ? Use of Prozac in the past 2 weeks.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the drug induced change in brain activity and neurometabolite concentration when comparing ayahuasca to baseline.	—

Secondary

Measure	Time frame
The change in subjective state and cognitive flexibility will be assessed and correlated with the neurological effects. The modulatory effects of the ceremonial setting on these changes will be evaluated through a controlled music paradigm.	—

Contacts

Public ContactPablo-Alexandre Mallaroni

Maastricht University

p.mallaroni@maastrichtuniversity.nl+31 (0)43 3881026

Outcome results