What is 5-MeO-DMT studying in this clinical trial?

This trial is studying the acute effects of intravenous 5-MeO-DMT in healthy adults. Researchers aim to understand how different doses affect subjective experiences and physiological responses. The University Hospital, Basel, Switzerland, is conducting the study to gather detailed safety and pharmacokinetic data.

Who may be eligible for this 5-MeO-DMT clinical trial?

Adults aged 25 to 65 who are healthy, understand German, and can follow study instructions may be eligible. People with major psychiatric or medical conditions, pregnant or breastfeeding individuals, and those using certain medications or substances may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this 5-MeO-DMT clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may not be covered and can vary. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase 1

Age: 25Years - 65Years

All Genders

Healthy Volunteers

ID07444788

Acute Subjective and Physiological Effects of Intravenous 5-MeO-DMT Infusions in Healthy Adults in a Double-Blind, Placebo-Controlled, Single Ascending Dose Study

Led by University Hospital, Basel, Switzerland · Updated on 2026-03-03

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the acute effects of intravenous 5-MeO-DMT in healthy adults aged 25 to 65 years. This phase 1, randomized, double-blind, placebo-controlled trial aims to understand subjective experiences, physiological changes, and pharmacokinetics after administering different doses of 5-MeO-DMT. The study is conducted by the University Hospital, Basel, Switzerland, and involves healthy volunteers without major psychiatric or medical conditions who can understand the German language and follow study procedures. Participants are randomly assigned to receive one of four ascending doses of 5-MeO-DMT 0.2, 0.4, 0.6, or 0.8 mgmin or a placebo saline, given intravenously over 30 minutes. The trial includes three on-site visits a screening visit lasting about 2 hours, a drug administration visit lasting approximately 4 hours, and a follow-up visit about one week later lasting 2 hours. During the administration visit, subjective experiences are repeatedly recorded, and blood pressure, heart rate, and blood samples are monitored. Throughout the study, participants complete various assessments including subjective effect scales, personality inventories, and safety evaluations. Outcome measurements track changes in subjective effects over time, vital signs, adverse events, laboratory parameters, and plasma drug concentrations. Safety and tolerability are monitored up to one week after substance administration. The total participation time spans approximately two weeks with careful observation and data collection during each visit.

CONDITIONS

Brief Title

Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants

Who Can Participate

Age: 25Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Age between 25 and 65 years old
Sufficient understanding of the German language
Understanding of procedures and risks associated with the study
Willingness to follow the study protocol and sign consent
Willing to avoid illicit psychoactive substances during the study
Willing not to operate heavy machinery for 48 hours after the study session
Willing to use effective birth control during study participation
Body mass index between 18 and 29 kg/m2

You will not qualify if you...

Having chronic or acute medical conditions
Current or past major psychiatric disorders
Psychotic or bipolar disorder in first-degree relatives
High blood pressure (above 140/90 mmHg) or low blood pressure (below 85 mmHg)
Use of hallucinogenic or dissociative substances more than 20 times or within the last two months (excluding cannabis)
Pregnancy or breastfeeding
Participation in another clinical trial within the last 30 days
Use of medications that may interfere with study medication
Smoking more than 10 cigarettes per day
Consuming more than 15 alcoholic drinks or 180g alcohol per week

Research Team

Livio Erne, MSc Drug Sciences

Severin B Vogt, Dr. med.

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