RecruitingPhase 1MDMA
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants
Sponsored by University Hospital, Basel, Switzerland
NCT ID
NCT06905652
Target Enrollment
24 participants
Start Date
2025-07-29
Est. Completion
2026-11
About This Study
Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA has been investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.
Conditions Studied
Interventions
- •R-3,4-methylenedioxymethamphetamine
- •S-3,4-methylenedioxymethamphetamine
- •Placebo
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:Yes
View full 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)
Study Locations (1)
University Hospital Basel
Basel, Canton of Basel-City, Switzerland