Status:
RECRUITING
Acute Effects of MDMA Co-administration on the Response to Psilocybin 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 psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust to...
Detailed Description
Psilocybin is a classic serotonergic psychedelic. Clinically, the acute effects of psilocybin last shorter than those of lysergic acid diethylamide (LSD) but are qualitatively very similar. Currently,...
Eligibility Criteria
Inclusion
- Age between 25 and 65 years.
- Understanding of the German language.
- Understanding the procedures and the risks that are associated with the study.
- Participants must be willing to adhere to the protocol and sign the consent form.
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
- Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
- Willing to use effective 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 in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
- Pregnant or nursing women.
- Participation in another clinical trial (currently or within the last 30 days).
- Use of medications that may interfere with the effects of the study medications.
- Tobacco smoking (\>10 cigarettes/day).
- Consumption of alcoholic drinks (\>15 drinks/week).
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06884514
Start Date
April 3 2025
End Date
July 1 2026
Last Update
May 21 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031