Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-65
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
0.2 mg/min 5-MeO-DMT
Drug0.2 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
0.4 mg/min 5-MeO-DMT
Drug0.4 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
0.6 mg/min 5-MeO-DMT
Drug0.6 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
0.8 mg/min 5-MeO-DMT
Drug0.8 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
Placebo
DrugPlacebo (saline) is administered for a total infusion duration of 30 min.
Treatment groups
40 Participants
are divided into 5 treatment groupsGroup A: 0.2 mg/min 5-MeO-DMTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: 0.4 mg/min 5-MeO-DMTExperimental treatment 1 intervention
Group D: 0.6 mg/min 5-MeO-DMTExperimental treatment 1 intervention
Group E: 0.8 mg/min 5-MeO-DMTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in subjective effects over time (assessed with subjective effect scales (SES))
Participants will be asked by the investigator to repeatedly rate their subjective effects verbally on a Likert scale from 0 to 10 for: "any drug effect", "good drug effect", "bad drug effect", and "fear". Ratings will be performed before and repeatedly after substance administration and will take approximately 30 sec to complete.
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 outcomes
1
Treatment-emergent adverse events (TEAEs)
A TEAE is an adverse event (AE) that emerges during treatment (having been absent before treatment) or that worsens after treatment. Spontaneously reported AEs, AEs in response to questioning or observed AEs by the investigators will be recorded at the substance administration session (Session 2) and at the end of study visit (EOS, Session 3). Clinically significant abnormalities in the results of a laboratory test, on the ECG or on suicidal ideation (C-SSRS) may also be recorded as TEAE. TEAEs will be summarized and tabulated by treatment (5-MeO-DMT vs. placebo).
Time frame
Up to one week (from substance administration session (Session 2) to end of study visit (EOS, Session 3))2
Change in Safety lab parameters
A routine safety laboratory blood test is performed at the screening (Session 1) and at the end of study visit (Session 3) including creatinine, alanine aminotransferase (ALAT), aspartate transaminase (ASAT), hemoglobin, hematocrit, white blood cell count, red blood cell count, and platelet cell count (total of 7.3 ml blood).
Time frame
Up to 14 days (from Screening (Session 1) until end-of-study-visit (EOS, Session 3))3
Change in Vital Signs
Blood pressure, heart rate, and body temperature will be recorded at baseline and repeatedly throughout the drug administration session (Session 2). Blood pressure (systolic and diastolic) and heart rate will be measured with an automatic oscillometric device. Measurements will be taken in supine position. For blood pressure, duplicate measurements will be performed.
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.4
Change in Adverse effects list (Beschwerdenliste (BL-R)
The Adverse effects list (= Beschwerdenliste) is a self-reporting tool to assess physical and general discomfort. We will use the 2011 revised version, which consists of a 40-item list to assess physiological complaints throughout the study sessions. The BL-R covers a wide variety of symptoms and complaints that are answered with a four-point Likert scale ranging from "not at all" to "strong". We added several items that have been frequently observed in previous research with psychedelics by the several research groups. The scale will be administered at baseline and at the end of the substance administration session (Session 2).
Time frame
Up to 4 hours at substance administration session (Session 2) (at baseline and after substance administration)Sponsors and contacts
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Source ClinicalTrials.gov