Acute intravenous 5-MeO-DMT effects in healthy adults

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

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
• Enrollment: 40 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 1 site (Basel, Canton of Basel-City)
• Trial ID: NCT07444788 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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)

Where this trial is running

Basel, Canton of Basel-City

• 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

Conditions 5-methoxy-dimethyltryptamine; Infusion; psychedelic