RecruitingPhase 1MDMA
Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants
Sponsored by University Hospital, Basel, Switzerland
NCT ID
NCT07494214
Target Enrollment
20 participants
Start Date
2026-03-09
Est. Completion
2027-04-09
About This Study
This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect). In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.
Conditions Studied
Interventions
- •MDMA 25 mg
- •MDMA 75 mg
- •MDMA 125 mg
- •Placebo
Eligibility
Age:18 Years - 75 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria: 1. Age between 18 and 75 years old 2. Sufficient 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 for 48 hours after the study session. 7. Willing to use effective birth control throughout study participation 8. Body mass index between 18-34.9 kg/m2 Exclusion Criteria: 1. Relevant chronic or acute medical condition 2. Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses) 3. Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder. 4. Psychotic disorder or bipolar disorder in first-degree relatives 5. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg) 6. Lifetime use of MDMA on more than 20 occasions or any use within the previous two months 7. Pregnancy or current breastfeeding 8. Participation in another clinical trial (currently or within the last 30 days) 9. Use of medication that may interfere with the effects of the study medication 10. Tobacco smoking (\>10 cigarettes/day) 11. Consumption of alcoholic beverages (\>15 drinks/week)
Study Locations (1)
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Switzerland