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L'essai clinique NCT07494214 (MDPS) pour Healhty est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS) Phase I 20
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07494214 (MDPS) est conçu pour étudier la recherche fondamentale de Healhty. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : en recrutement. L'étude a débuté le 9 mars 2026 et vise à recruter 20 participants. Dirigée par University Hospital, Basel, Switzerland, l'étude devrait être terminée d'ici le 9 avril 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 mars 2026.
Résumé succinct
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...
Afficher plusDescription détaillée
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...Afficher plus
Titre officiel
Acute Analgesic Effects of 3,4-methylenedioxymethamphetamine (MDMA) on Experimentally Induced Acute Nociceptive Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS-study)
Pathologies
HealhtyAutres identifiants de l'étude
- MDPS
- BASEC 2025-01212
Numéro NCT
Date de début (réel)
2026-03-09
Dernière mise à jour publiée
2026-03-27
Date de fin (estimée)
2027-04-09
Inscription (estimée)
20
Type d'étude
Interventionnel
PHASE
Phase I
Statut
En recrutement
Objectif principal
Recherche fondamentale
Méthode d'allocation
Randomisé
Modèle d'intervention
Étude croisée
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalMDMA 25 mg | MDMA 25 mg oral administration |
ExpérimentalMDMA 75 mg | MDMA 75 mg oral administration |
ExpérimentalMDMA 125 mg | MDMA 125 mg oral administration |
ExpérimentalPlacebo | PLACEBO oral administration |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
NRS | Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition. | Periprocedural |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Age between 18 and 75 years old
- Sufficient understanding of the German language
- Understanding of procedures and risks associated with the study
- Willing to adhere to the protocol and signing of the consent form
- Willing to refrain from the consumption of illicit psychoactive substances during the study
- Willing not to operate heavy machinery for 48 hours after the study session.
- Willing to use effective birth control throughout study participation
- Body mass index between 18-34.9 kg/m2
- Relevant chronic or acute medical condition
- Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses)
- Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder.
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Lifetime use of MDMA on more than 20 occasions or any use within the previous two months
- Pregnancy or current breastfeeding
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medication that may interfere with the effects of the study medication
- Tobacco smoking (>10 cigarettes/day)
- Consumption of alcoholic beverages (>15 drinks/week)
University Hospital, Basel, SwitzerlandContact central de l'étude
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 Centres de l'étude dans 1 pays
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]
En recrutement