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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT05695495
Eligibility Criteria:
Inclusion Criteria:
1. Age between 25 and 65 years old
2. Sufficient understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during the study
6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
7. Willing not to operate heavy machinery within 6 h of DMT administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2.
Exclusion Criteria:
1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medication that may interfere with the effects of the study medication
9. Tobacco smoking (\>10 cigarettes/day)
10. Consumption of alcoholic beverages (\>20 drinks/week)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05695495
Study Brief:
Protocol Section:
NCT05695495