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

Acute Analgesic Effects of 3,4-methylenedioxymethamphetamine (MDMA) on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS-study)

The researchers will test whether single oral doses of MDMA reduce experimentally induced acute pain, hyperalgesia, and allodynia in healthy adult volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 1 site (Basel)
• Trial ID: NCT07494214 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are German-speaking healthy adults aged 18–75 with BMI 18–34.9 kg/m2, willing to follow study rules, avoid illicit psychoactive drugs during participation, and use effective birth control when applicable.

Not a fit: People with relevant chronic or acute medical conditions, implanted medical devices, major psychiatric disorders or uncontrolled blood pressure would not be expected to benefit and are excluded from participation.

Why it matters

Potential benefit: If successful, this work could identify acute analgesic effects of MDMA and inform development of new approaches for treating pain conditions.

How similar studies have performed: Small case series and early clinical trials have suggested MDMA may affect pain and related neurotransmitter systems, but rigorous randomized data on acute analgesic effects are lacking.

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)

Where this trial is running

Basel

• Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Switzerland (Recruiting)

Study contacts

• Study coordinator: Severin B Vogt, Dr. med.

Conditions Healhty