Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT06150859
Eligibility Criteria:
Inclusion Criteria:
* Experienced the loss of a first- degree relative not more than 12 months prior to enrollment as indicated by self-report.
* Scores up to 40 in the Texas Revised Inventory of Grief (TRIG).
Exclusion Criteria:
* Pregnant or breastfeeding women.
* Hypertension (systolic blood pressure above 140 mm, diastolic above 90 mm and heart rate above 100 bpm).
* History of psychotic disorder (Axis I-II of the DSM-V).
* Substance use disorder (except nicotine).
* Alcohol consumption greater than 40 g/day.
* Receiving psychological or self-help therapy during the study on a regular basis.
* Receiving regular pharmacological therapy for complicated grief during the study.
* Regular intake of any type of medication in the month preceding the study.
* Treatment with single doses of symptomatic medication during the study may be accepted (as long as it can be assumed that the ingested drug has been completely eliminated on the days of the ayahuasca administrations).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06150859
Study Brief:
Protocol Section:
NCT06150859