Acute intravenous 5-MeO-DMT effects in healthy adults
Official title: Acute Subjective Effects, Physiological Effects, and Pharmacokinetics of Intravenous 5-MeO-DMT Infusions in a Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Participants
Run by University Hospital, Basel, Switzerland · NCT07444788 · Data updated 2026-11-12
This research will test whether a 30-minute intravenous infusion of 5-MeO-DMT produces acute physiological and subjective effects in healthy adults aged 25–65.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07444788 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy German-speaking adults aged 25–65 with BMI 18–29 kg/m2, no major medical or psychiatric history, willing to avoid illicit psychoactive substances and to use effective birth control during participation.
✕Probably not a fit
People with chronic medical conditions, current or past major psychiatric disorders, a relevant family history of psychosis or bipolar disorder, recent or heavy hallucinogen use, abnormal blood pressure, pregnancy or breastfeeding, or inability to attend on-site visits would not be eligible and are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Healthy volunteers attend three on-site visits over about two weeks: a screening visit, a drug-administration visit, and a one-week follow-up. Participants are randomized, double-blind, to receive placebo or one of four infusion rates of 5-MeO-DMT (0.2, 0.4, 0.6, or 0.8 mg/min) administered over 30 minutes. Blood pressure and heart rate are monitored and participants are repeatedly asked to report their subjective experiences during and after the infusion. This Phase 1 interventional trial focuses on acute safety, tolerability, and dose-related effect characterization in a controlled clinical setting.
Why it matters
Potential benefit: If successful, this could clarify acute safety and dose-related effect profiles for intravenous 5-MeO-DMT and help guide safe dosing in future therapeutic research.
How similar studies have gone: Small and early reports of 5-MeO-DMT and other fast-acting tryptamines show pronounced subjective effects, but controlled intravenous dose-escalation data are limited, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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University Hospital Basel
Basel, Canton of Basel-City, Switzerland Recruiting
Study contacts
- Principal investigator: Severin Vogt, Dr. med. — University Hospital Basel, Division of Clinical Pharmacology and Toxicology
- Study coordinator: Livio Erne, MSc Drug Sciences
- Email: livio.erne@usb.ch
- Phone: +41613284818
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.