MedPath

Santo Daime study

Recruiting
Conditions
/A
Registration Number
NL-OMON21269
Lead Sponsor
Maastricht University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
25
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

? 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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main study parameter is the drug induced change in brain activity and neurometabolite concentration when comparing ayahuasca to baseline.
Secondary Outcome Measures
NameTimeMethod
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.
© Copyright 2025. All Rights Reserved by MedPath