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Clinical TrialHealthy VolunteersMDMAMDMAMDMAPlaceboRecruiting

Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants

This Phase I, randomised, triple-masked, crossover trial (n=20) will assess the acute analgesic effects of oral MDMA in healthy adults aged 18 to 75 years. It will compare MDMA 25 mg, 75 mg and 125 mg with placebo to evaluate whether MDMA reduces experimentally induced acute nociceptive pain, hyperalgesia and allodynia. Participants will receive the study drug by mouth during a validated electrical stimulation pain model in which repeated small electrical pulses are applied under the skin to produce moderate pain and secondary pain phenomena. The main outcome is periprocedural pain measured with the numerical rating scale, with the highest MDMA dose compared against the lower doses and placebo.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

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.

Study Arms & Interventions

MDMA 25 mg

experimental

Interventions

  • MDMA25 mg
    via Oral• single dose• 1 doses total

MDMA 75 mg

experimental

Interventions

  • MDMA75 mg
    via Oral• single dose• 1 doses total

MDMA 125 mg

experimental

Interventions

  • MDMA125 mg
    via Oral• single dose• 1 doses total

Placebo

experimental

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

Participants

Ages
18 – 75
Sexes
Male & Female

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 Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2026-03-09
    End: 2027-04-09
  • Compounds
    MDMAMDMAMDMAPlacebo
  • Topic
    Healthy Volunteers

Study Team

Sponsors & Collaborators

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Switzerland

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