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Recruiting NCT07444788

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

Phase I Interventional 5-methoxy-dimethyltryptamine (5-MeO-DMT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.2 mg/min 5-MeO-DMT, 0.4 mg/min 5-MeO-DMT, 0.6 mg/min 5-MeO-DMT, 0.8 mg/min 5-MeO-DMT.
Who it may be relevant to
Registry conditions: 5-methoxy-dimethyltryptamine (5-MeO-DMT). Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 0.2 mg/min 5-MeO-DMT
    0.2 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Drug 0.4 mg/min 5-MeO-DMT
    0.4 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Drug 0.6 mg/min 5-MeO-DMT
    0.6 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Drug 0.8 mg/min 5-MeO-DMT
    0.8 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Drug Placebo
    Placebo (saline) is administered for a total infusion duration of 30 min.

Primary outcome measures

  • Change in subjective effects over time (assessed with subjective effect scales (SES)) [Time frame: Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.]
Secondary outcome measures (12)
  • Treatment-emergent adverse events (TEAEs) [Time frame: Up to one week (from substance administration session (Session 2) to end of study visit (EOS, Session 3))]
  • Change in Safety lab parameters [Time frame: Up to 14 days (from Screening (Session 1) until end-of-study-visit (EOS, Session 3))]
  • Change in Vital Signs [Time frame: Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.]
  • Change in Adverse effects list (Beschwerdenliste (BL-R) [Time frame: Up to 4 hours at substance administration session (Session 2) (at baseline and after substance administration)]
  • Swiss Psychedelic Side Effects Inventory (SPSI) [Time frame: One time assessment at End-of-study-visit (EOS, Session 3 = 7 days after substance administration)]
  • Change in Columbia-Suicide-Severity-Rating-Scale (C-SSRS) [Time frame: Up to 14 days (from Screening (Session 1) to Substance administration session (Session 2) until End-of-study-visit (EOS, Session 3))]
  • 5-Dimensions of Altered States of Consciousness Scale (5D-ASC) [Time frame: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • States of Consciousness Questionnaire (SCQ) [Time frame: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • Ego dissolution inventory (EDI) [Time frame: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • Near-death experience content scale (NDE-C) [Time frame: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • Emotional Breakthrough Inventory Plus (EBI+) [Time frame: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • PAE-PS-ext (PAE-PS-ext) [Time frame: One time assessment at substance administration session (Session 2): 3 hours after substance administration.]

Eligibility criteria

Inclusion criteria

  • Age between 25 and 65 years old
  • Sufficient understanding of the German language
  • Understanding of procedures and risks associated with the study
  • Willing to adhere to the protocol and signing of the consent form
  • Willing to refrain from the consumption of 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 throughout study participation
  • Body mass index between 18-29 kg/m2

Exclusion criteria

  • Chronic or acute medical condition
  • Current or previous major psychiatric disorder
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • Hallucinogenic and/or dissociative substance use (not including cannabis) more than 20 times or any time within the previous two months
  • Pregnancy or current breastfeeding
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medication that may interfere with the effects of the study medication
  • Tobacco smoking (>10 cigarettes/day)
  • Consumption of alcoholic beverages (>15 drinks or >180g alcohol per week)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT07444788 · 2025-02387;am25Vogt2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗