Actively Recruiting
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
Led by University Hospital, Basel, Switzerland · Updated on 2025-05-21
24
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If administered in combination with psilocybin, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with psilocybin and overall produce a more positive over negative experience. The present study will assess subjective and autonomic effects of psilocybin alone and in combination with MDMA.
CONDITIONS
Official Title
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 25 and 65 years
- Understanding of the German language
- Understanding of study procedures and risks
- Willingness to follow study rules and sign consent
- Willingness to avoid illicit psychoactive substances during study
- Willingness to drink only alcohol-free liquids and avoid coffee, black or green tea, or energy drinks after midnight before study sessions
- Willingness not to drive or operate machines for 48 hours after substance use
- Use of effective birth control throughout study participation
- Body mass index between 18 and 29 kg/m2
You will not qualify if you...
- Any chronic or acute medical condition
- Current or past major psychiatric disorder
- Psychotic disorder in first-degree relatives (except those caused by medical reasons)
- High blood pressure (above 140/90 mmHg) or low blood pressure (below 85 mmHg)
- Illicit substance use (excluding cannabis) more than 20 times or within the last month
- Pregnant or nursing women
- Participation in another clinical trial currently or within the last 30 days
- Use of medications that may interfere with study drugs
- Smoking more than 10 cigarettes per day
- Drinking more than 15 alcoholic drinks per week
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Matthias E Liechti, Prof. Dr. MD
CONTACT
I
Isabelle Straumann, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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