Status:
COMPLETED
Acute Dose-dependent Effects of DMT in Healthy Subjects
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
Brief Summary
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 mode...
Detailed Description
N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consc...
Eligibility Criteria
Inclusion
- 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
- Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
- Willing not to operate heavy machinery within 6 h of DMT administration
- Willing to use double-barrier birth control throughout study participation
- Body mass index between 18-29 kg/m2
Exclusion
- Chronic or acute medical condition
- Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- Hallucinogenic 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 (\>20 drinks/week)
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05384678
Start Date
November 15 2022
End Date
March 13 2024
Last Update
April 25 2024
Active Locations (1)
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1
Universtity Hospital Basel
Basel, Switzerland, 4056