NCT07444788 Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants
| NCT ID | NCT07444788 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | 5-methoxy-dimethyltryptamine (5-MeO-DMT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-03-31 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Participation in this study lasts approximately two weeks and includes three on-site study visits: a screening visit (approximately 2 hours), a study drug administration visit (approximately 4 hours), and a follow-up visit approximately one week later (approximately 2 hours). If participants decide to take part in the study and meet the inclusion and exclusion criteria, they will be randomly assigned to one of two groups: an experimental group or a control group. Participants will not be informed of your group assignment. Participants in the experimental group will receive the investigational substance 5-MeO-DMT at a dose of 0.2, 0.4, 0.6, or 0.8 mg/min for a total infusion duration of 30 min. Participants in the control group will receive a placebo that is indistinguishable in appearance from the investigational substance. Following substance administration, participants will be repeatedly asked to describe their subjective experiences. Blood pressure and heart rate will be monitored regularly, and blood samples will be collected via an intravenous catheter.
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. Willing not to operate heavy machinery for 48 hours after the study session. 7. Willing to use effective birth control throughout study participation 8. Body mass index between 18-29 kg/m2 Exclusion Criteria: 1. Chronic or acute medical condition 2. Current or previous major psychiatric disorder 3. Psychotic disorder or bipolar disorder in first-degree relatives 4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg) 5. Hallucinogenic and/or dissociative 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 (\>15 drinks or \>180g alcohol per week)
Contact & Investigator
Severin Vogt, Dr. med.
PRINCIPAL INVESTIGATOR
University Hospital Basel, Division of Clinical Pharmacology and Toxicology
Frequently Asked Questions
Who can join the NCT07444788 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying 5-methoxy-dimethyltryptamine (5-MeO-DMT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07444788 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07444788 currently recruiting?
Yes, NCT07444788 is actively recruiting participants. Contact the research team at livio.erne@usb.ch for enrollment information.
Where is the NCT07444788 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT07444788 clinical trial?
NCT07444788 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Severin Vogt, Dr. med. at University Hospital Basel, Division of Clinical Pharmacology and Toxicology. The trial plans to enroll 40 participants.