Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two forms of MDMA, a substance known to enhance feelings of happiness, empathy, and connection to others. The goal is to compare how these two forms, R-MDMA and S-MDMA, affect healthy participants. This research is important because MDMA has been explored as a potential treatment for conditions like post-traumatic stress disorder (PTSD) in previous studies.

To participate in this trial, you need to be between 18 and 65 years old, speak German well, and understand the study's procedures and risks. It's essential that you're willing to follow the study rules, which include not using illegal drugs during the study and avoiding heavy machinery for 48 hours after taking the study substance. Participants must also have a body mass index (BMI) between 18 and 34.9. However, people with certain medical conditions, significant mental health issues, or who smoke heavily or drink excessively will not be eligible. If you join, you can expect to help researchers learn more about how different forms of MDMA may affect mood and social feelings, which could be beneficial for future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 65 years
• • 2. Good understanding of the German language
• • 3. Understanding of procedures and risks associated with the study
• • 4. Willing to adhere to the protocol and signing of the consent form
• • 5. Willing to refrain from the consumption of illicit psychoactive substances during the study
• • 6. Willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car)
• • 7. Willing to use effective birth-control throughout study participation.
• • 8. Body mass index 18 - 34.9 kg/m2
• Exclusion Criteria:
• • 1. Relevant chronic or acute medical condition
• • 2. Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder
• • 3. Psychotic disorder or bipolar disorder in first-degree relatives
• • 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. Pregnancy or current breastfeeding
• • 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 medication
• • 9. Tobacco smoking (\>10 cigarettes/day).
• • 10. Excessive consumption of alcoholic beverages (\>15 drinks/week)