Status:
COMPLETED
Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
Brief Summary
The acute subjective effects of serotonin (5-HT)2A receptor stimulation with lysergic acid diethylamide (LSD) in humans are mostly positive. However, negative effects such as anxiety, paranoid thinkin...
Detailed Description
LSD is a so-called "classic" or serotonergic hallucinogen or psychedelic. Its psychedelic effects are mainly attributed to its potent partial serotonin (5-HT) 5-HT2A receptor agonism. The effects of L...
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 48 h of substance 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
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- Use of hallucinogenic substances (not including cannabis) more than 20 times or any time within the previous two months
- Use of MDMA more than 20 times or any time within the previous two months
- Pregnancy or currently 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 :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04516902
Start Date
January 1 2021
End Date
August 22 2022
Last Update
August 23 2022
Active Locations (1)
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1
University Hospital Basel, Clinical Trial Unit
Basel, Canton of Basel-City, Switzerland, 4056