About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 75 years old
Sufficient understanding of the German language
Understanding of procedures and risks associated with the study
Willing to adhere to the protocol and signing of the consent form
Disqualifiers
Relevant chronic or acute medical condition
Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses)
Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder.
Psychotic disorder or bipolar disorder in first-degree relatives
Trial design
Crossover
Treatments tested in this trial
MDMA 25 mg
Drugoral administration
MDMA 75 mg
Drugoral administration
MDMA 125 mg
Drugoral administration
Placebo
Drugoral administration
Treatment groups
Trial outcomes
Primary outcomes
NRS
Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.
Secondary outcomes
Hyperalgesia and Allodnyia
Difference of the cumulative areas of hyperalgesia and allodynia (AUECs) between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition.
Subjective effects and NRS ratings
Correlation between subjective effect ratings on the VAS (AUEC) and NRS pain scores and areas of hyperalgesia and allodynia (AUEC).
Endocrine effects
oxytocin and cortisol serum levels
NRS dose-dependent effects
Difference of the cumulative NRS scores between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition.
Sponsors and contacts
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