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Clinical Trial NCT07494214 (MDPS) for Healhty is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS) Phase 1 20

Recruiting
Clinical Trial NCT07494214 (MDPS) is designed to study Basic Science for Healhty. It is a Phase 1 interventional study that is recruiting, having started on March 9, 2026, with plans to enroll 20 participants. Led by University Hospital, Basel, Switzerland, it is expected to complete by April 9, 2027. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief Summary
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 t...

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Detailed Description
Preliminary evidence from case series and small clinical trials suggests that 3,4-methylenedioxymethamphetamine (MDMA) may be promising candidates for the treatment of chronic or neuropathic pain. Moreover, MDMA potently releases serotonin, noradrenalin and oxytocin, which are implicated in the modulation of pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the po...Show More
Official Title

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

Conditions
Healhty
Other Study IDs
  • MDPS
  • BASEC 2025-01212
NCT ID Number
NCT07494214
Start Date (Actual)
2026-03-09
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-04-09
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMDMA 25 mg
MDMA 25 mg
oral administration
ExperimentalMDMA 75 mg
MDMA 75 mg
oral administration
ExperimentalMDMA 125 mg
MDMA 125 mg
oral administration
ExperimentalPlacebo
Placebo
oral administration
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
NRS
Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.
Periprocedural
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Periprocedural
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).
Periprocedural
Endocrine effects
oxytocin and cortisol serum levels
Periprocedural
NRS dose-dependent effects
Difference of the cumulative NRS scores between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition.
Periprocedural
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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

  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)
University Hospital, Basel, Switzerland logoUniversity Hospital, Basel, Switzerland
Study Central Contact
Contact: Severin B Vogt, Dr. med., +41 61 268 68 66, [email protected]
Contact: Matthias E Liechti, Prof., +41 61 268 68 86, [email protected]
1 Study Locations in 1 Countries
Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, 4056, Switzerland
Severin B Vogt, Dr. med., Contact, +41 61 268 68 66, [email protected]
Matthias E Liechti, Prof., Contact, +41 61 268 68 86, [email protected]
Recruiting