bèta
Trial Radar AI
De klinische studie NCT07494214 (MDPS) voor Healhty is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
Eén studie komt overeen met de filtercriteria
Kaartweergave
Terug naar zoekresultaten

Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants (MDPS) Fase 1 20

Rekruterend
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT07494214 (MDPS) onderzoekt basiswetenschap bij Healhty. Deze Fase 1 interventioneel-studie heeft de status rekruterend. Het doel is om 20 deelnemers te includeren vanaf 9 maart 2026. De studie wordt geleid door University Hospital, Basel, Switzerland en de voltooiing is gepland op 9 april 2027. Laatste update op ClinicalTrials.gov: 27 maart 2026.
Beknopte samenvatting
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...

Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële titel

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

Aandoeningen
Healhty
Andere studie-ID's
  • MDPS
  • BASEC 2025-01212
NCT-ID
NCT07494214
Startdatum (Werkelijk)
2026-03-09
Laatste update geplaatst
2026-03-27
Verwachte einddatum
2027-04-09
Inschrijving (Geschat)
20
Studietype
Interventioneel
FASE
Fase 1
Status
Rekruterend
Primaire doel
Basiswetenschap
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Drievoudig blind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelMDMA 25 mg
MDMA 25 mg
oral administration
ExperimenteelMDMA 75 mg
MDMA 75 mg
oral administration
ExperimenteelMDMA 125 mg
MDMA 125 mg
oral administration
ExperimenteelPlacebo
PLACEBO
oral administration
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
NRS
Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.
Periprocedural
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
  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
Centraal Contactpersoon
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 Studielocaties in 1 landen
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]
Rekruterend