NCT07494214

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 the artificially created pain. A total of 20 healthy volunteers will take part in this study.

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.

Conditions

• Healhty

Interventions

Type	Name	Description
DRUG	MDMA 25 mg	oral administration
DRUG	MDMA 75 mg	oral administration
DRUG	MDMA 125 mg	oral administration
DRUG	Placebo	oral administration

Timeline

• Start date: 2026-03-09
• Primary completion: 2027-03-09
• Completion: 2027-04-09
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Switzerland