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

Neurometabolites and functional brain connectivity in experienced ayahuasca users of the Santo Daime Church before and after drinking the psychedelic ayahuasca brew: an observational study - The effect of Ayahuasca on brain function and cognitive flexibility

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50144
Enrollment
20
Registered
2020-03-11
Start date
2020-09-05
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

no condition NA

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion 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

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

Secondary

MeasureTime frame
Additionally, the change in subjective state and cognitive flexibility will be assessed and correlated with the neurological effects. Lastly, we will evaluate the modulatory effects of the ceremonial setting on these changes through a controlled music paradigm.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)