Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants (MEOS)

University Hospital Basel

Status and phase: Enrolling; Phase 1

Conditions: 5-methoxy-dimethyltryptamine (5-MeO-DMT)

Treatments: Drug: 0.2 mg/min 5-MeO-DMT; Drug: Placebo; Drug: 0.6 mg/min 5-MeO-DMT; Drug: 0.8 mg/min 5-MeO-DMT; Drug: 0.4 mg/min 5-MeO-DMT

Study type: Interventional

Funder types: Other

Identifiers

NCT07444788

2025-02387 am25Vogt2;

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups, including a placebo group

0.2 mg/min 5-MeO-DMT

Experimental group

Description:

0.2 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.

Treatment:

Drug: 0.2 mg/min 5-MeO-DMT

Placebo

Placebo Comparator group

Description:

Placebo (saline) will be administered for a total infusion duration of 30 min.

Treatment:

Drug: Placebo

0.4 mg/min 5-MeO-DMT

Experimental group

Description:

0.4 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.

Treatment:

Drug: 0.4 mg/min 5-MeO-DMT

0.6 mg/min 5-MeO-DMT

Experimental group

Description:

0.6 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.

Treatment:

Drug: 0.6 mg/min 5-MeO-DMT

0.8 mg/min 5-MeO-DMT

Experimental group

Description:

0.8 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.

Treatment:

Drug: 0.8 mg/min 5-MeO-DMT