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Lo studio clinico NCT07494214 (MDPS) per Healhty è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS) Fase I 20

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07494214 (MDPS) è uno studio interventistico di Fase I volto a esaminare la ricerca di base per Healhty, attualmente in arruolamento. Avviato il 9 marzo 2026, prevede di arruolare 20 partecipanti. Sotto la guida di University Hospital, Basel, Switzerland, dovrebbe concludersi entro il 9 aprile 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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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Descrizione dettagliata
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...Mostra di più
Titolo ufficiale

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

Patologie
Healhty
Altri ID dello studio
  • MDPS
  • BASEC 2025-01212
Numero NCT
NCT07494214
Data di inizio (effettiva)
2026-03-09
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-04-09
Arruolamento (previsto)
20
Tipo di studio
Interventistico
FASE
Fase I
Stato
In arruolamento
Scopo principale
Ricerca di base
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Triplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleMDMA 25 mg
MDMA 25 mg
oral administration
SperimentaleMDMA 75 mg
MDMA 75 mg
oral administration
SperimentaleMDMA 125 mg
MDMA 125 mg
oral administration
SperimentalePlacebo
PLACEBO
oral administration
Esito primario
Misure di esitoDescrizione della misuraArco temporale
NRS
Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.
Periprocedural
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
  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
Contatti principali dello studio
Contatto: Severin B Vogt, Dr. med., +41 61 268 68 66, [email protected]
Contatto: Matthias E Liechti, Prof., +41 61 268 68 86, [email protected]
1 Centri dello studio in 1 paesi
Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, 4056, Switzerland
Severin B Vogt, Dr. med., Contatto, +41 61 268 68 66, [email protected]
Matthias E Liechti, Prof., Contatto, +41 61 268 68 86, [email protected]
In arruolamento