CompletedPhase 1DMT
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study)
Sponsored by University Hospital, Basel, Switzerland
NCT ID
NCT05695495
Target Enrollment
36 participants
Start Date
2024-06-12
Est. Completion
2025-03-04
About This Study
N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.
Conditions Studied
Interventions
- •N,N-Dimethyltryptamine (5mg)
- •N,N-Dimethyltryptamine (10mg)
- •N,N-Dimethyltryptamine (15mg)
- •N,N-Dimethyltryptamine (20mg)
- •N,N-Dimethyltryptamine (25mg)
- •Placebo (saline)
Eligibility
Age:25 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility criteria
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)
Study Locations (1)
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Switzerland