Santo Daime study
- 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
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.
? 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
Name Time Method The main study parameter is the drug induced change in brain activity and neurometabolite concentration when comparing ayahuasca to baseline.
- Secondary Outcome Measures
Name Time Method 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.