MDMA for short-term reduction of experimentally induced pain in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial enrolls 20 healthy adult volunteers to compare single oral doses of MDMA (25 mg, 75 mg, 125 mg) with placebo using a validated electrical stimulation model that produces acute nociceptive pain as well as hyperalgesia and allodynia. Pain is induced by repeated small electrical pulses under the skin while participants receive MDMA or placebo, allowing direct comparison of dose-related acute analgesic effects. The protocol measures multiple pain qualities and secondary pain phenomena to characterize whether MDMA has antinociceptive or modulatory effects. Safety and tolerability are monitored throughout the sessions given the psychoactive nature of MDMA.

Why it matters

Who can join: the full rules

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)

Where it's running

• Clinical Pharmacology & Toxicology, University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Severin B Vogt, Dr. med.
• Email: severinbenjamin.vogt@usb.ch
• Phone: +41 61 268 68 66

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.