Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a combination of two substances, MDMA and psilocybin, affects healthy adults. Psilocybin is known to have both positive and negative effects on mood and perception, such as feelings of anxiety or paranoia, depending on the dose and individual factors. MDMA, on the other hand, tends to promote positive feelings like happiness and trust. The goal of this study is to see if taking MDMA alongside psilocybin can enhance the good effects of psilocybin and reduce the bad ones, potentially leading to a more positive experience overall.

To participate in this trial, you need to be between 25 and 65 years old, speak German, and understand the study's risks and procedures. You should also be willing to avoid certain substances like alcohol and illicit drugs during the study. Participants will be monitored closely, and they should not drive or operate machinery for 48 hours after taking the substances. This study is currently recruiting, so if you meet the eligibility criteria and are interested, you could help researchers learn more about how these substances work together.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 25 and 65 years.
• • 2. Understanding of the German language.
• • 3. Understanding the procedures and the risks that are associated with the study.
• • 4. Participants must be willing to adhere to the protocol and sign the consent form.
• • 5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
• • 6. 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.
• • 7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
• • 8. Willing to use effective 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
• • 3. 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.
• • 4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
• • 5. Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
• • 6. Pregnant or nursing women.
• • 7. Participation in another clinical trial (currently or within the last 30 days).
• • 8. Use of medications that may interfere with the effects of the study medications.
• • 9. Tobacco smoking (\>10 cigarettes/day).
• • 10. Consumption of alcoholic drinks (\>15 drinks/week).