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

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

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 Overview

• Status: Recruiting
• Conditions: Healhty
• Intervention / Treatment: Drug: Placebo; Drug: MDMA 25 mg; Drug: MDMA 75 mg; Drug: MDMA 125 mg

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 potential acute analgesic properties of MDMA remain poorly characterized. For instance, it is unclear whether MDMA possesses acute antinociceptive effects or if it rather modulate secondary pain phenomena such as hyperalgesia, allodynia, and/or functional pain. Here, the investigators will employ a validated electrical stimulation model in healthy volunteers that produces acute nociceptive pain but also features of chronic pain such as hyperalgesia and allodynia. The model is established for the detailed assessment of the analgesic effect of known analgesics or new compounds. Thus, the investigators will evaluate the efficacy of MDMA on different pain qualities within this model. The analgesic efficacy of MDMA 125 mg will be compared to MDMA 75 mg, MDMA 25 mg and placebo.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Severin B Vogt, Dr. med.; Phone Number: +41 61 268 68 66; Email: severinbenjamin.vogt@usb.ch
• Study Contact Backup: Name: Matthias E Liechti, Prof.; Phone Number: +41 61 268 68 86; Email: matthias.liechti@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Recruiting
    • Clinical Pharmacology & Toxicology, University Hospital Basel
    • Contact: Severin B Vogt, Dr. med.; Phone Number: +41 61 268 68 66; Email: severinbenjamin.vogt@usb.ch
    • Contact: Matthias E Liechti, Prof.; Phone Number: +41 61 268 68 86; Email: matthias.liechti@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Drug: Placebo; oral administration
Experimental: MDMA 25 mg	Drug: MDMA 25 mg; oral administration
Experimental: MDMA 75 mg	Drug: MDMA 75 mg; oral administration
Experimental: MDMA 125 mg	Drug: MDMA 125 mg; oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): April 9, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Amines; Phenethylamines; Ethylamines; Amphetamines; N-Methyl-3,4-methylenedioxyamphetamine
• Other Study ID Numbers: BASEC 2025-01212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No