Acute analgesic effects of 3,4-methylenedioxymethamphetamine (MDMA) on experimentally induced acute nociceptive pain, hyperalgesia, and allodynia in healthy subjects.
Zusammenfassung der Studie
MDMA is a psychoactive substance known by the street name 'Ecstasy', which primarily releases serotonin and norepinephrine in the brain through its action on the respective transporter protein. In recent years, MDMA has been studied in various trials both in healthy individuals and in different mental health disorders, but it has not yet been approved as a medication. This study investigates whether MDMA potentially has analgesic effects. The effects of MDMA are compared with a placebo. To examine the suspected analgesic potential of MDMA, healthy participants receive repetitive electrical shocks under the skin, which lead to moderate pain. At the same time, participants take oral doses of MDMA (125 mg, 75 mg, 25 mg) or a placebo to investigate the effect of each substance on the artificially induced pain. A potential healing effect of MDMA outside of this experimental framework is not examined in this study.
(BASEC)
Untersuchte Intervention
In this study, we investigate the analgesic potential of MDMA on experimentally induced pain caused by repetitive mild electrical shocks under the skin. For this purpose, two membranes are inserted under the skin on the front of your forearm through two small skin punctures. The membranes are each attached to a small needle. The membranes are then pulled parallel under the skin over a distance of about 2 cm. The skin is then pierced again by the needles (puncture site), and the membranes are attached to the skin externally. The membranes are connected via a fine wire and a cable to an external electrical stimulator. Through the electrical stimulator, you will receive mild electrical shocks (maximum strength 30 mA) at a constant frequency, which will cause you moderate pain. The total duration of this repetitive electrical stimulation is three hours. During this time, you will be repeatedly asked to describe your pain and the experienced effects. Additionally, your pain sensitivity will be tested repeatedly with two simple clinical tests. One involves applying light pressure at various points on your forearm with a thin glass fiber rod. The other involves being touched at various points on your forearm with a cotton swab. You will be asked to indicate in which areas of the skin your pain perception has changed and/or worsened. Blood pressure and pulse will be regularly measured on the other arm, and blood will be drawn through a venous catheter.
(BASEC)
Untersuchte Krankheit(en)
Healthy participants
(BASEC)
Age between 18 and 75 years - Good understanding of the German language - Body mass index between 18 – 34.9 kg/m² - Understanding of the procedures and risks associated with the study - Willingness to adhere to the protocol and sign the consent form - Willingness to refrain from using illegal psychoactive substances during the study - Willingness to refrain from operating heavy machinery within 48 hours after administration of a study substance - Willingness to use an effective contraceptive method throughout the entire study participation (BASEC)
Ausschlusskriterien
- Relevant chronic or acute medical condition - Current or past severe psychiatric disorder (e.g., psychotic disorder) - Psychotic disorder or bipolar disorder in first-degree relatives - Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg) - Pregnancy or currently breastfeeding - Participation in another clinical study (currently or in the last 30 days) - Use of medications that could affect the action of the study medication - Smoking tobacco (>10 cigarettes/day) - Excessive consumption of alcoholic beverages (>15 drinks/week) (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
Division of Clinical Pharmacology and Toxicology, University Hospital Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Severin Vogt
+41 61 328 68 66
severinbenjamin.vogt@clutterusb.chDivision of Clinical Pharmacology and Toxicology, University Hospital Basel
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.07.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Acute analgesic effects of 3,4-methylenedioxymethamphetamine (MDMA) on experimentally induced acute nociceptive pain, hyperalgesia and allodynia in healthy participants (BASEC)
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