Acute Dose-dependent Effects of DMT-bolus... — Clinical Trial Details

This randomized, crossover study in healthy volunteers uses intravenous DMT bolus doses (5, 10, 15, 20 mg; escalation arm includes 25 mg) and saline placebo to map dose–response relationships for subjective experience and autonomic effects.

Bolus applications are given as 45-second IV injections separated by one hour; outcomes include subjective ratings and physiological measures (blood pressure, heart rate, autonomic parameters).

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. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
7. Willing not to operate heavy machinery within 6 h of DMT administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2.

Exclusion Criteria:
1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
5. Hallucinogenic 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 (>20 drinks/week)

Company

Product

Legal

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study) (DMT BDR)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Dose-dependent pharmacokinetics and acute effects of intravenous bolus N,N-dimethyltryptamine: double-blind, randomized versus open-label dose-escalation administration study in healthy participants

Integration

Study Arms & Interventions

Randomized

Interventions

Dose escalation

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators