Co-administration of Psilocybin and MDMA in healthy individuals
Zusammenfassung der Studie
The study investigates the altered state of consciousness induced by the combined administration of the substances Psilocybin and MDMA compared to the sole administration of Psilocybin. Psilocybin is classified as a so-called 'classic' hallucinogen, acting on a specific serotonin receptor (5-HT2A receptor), while MDMA is referred to as an entactogen and releases both serotonin and oxytocin. Both substances are not approved as medications but have been used in various studies with healthy subjects and patients. A potential therapeutic effect of Psilocybin and MDMA is not investigated in this study. In the context of the study, you will receive 1 x Psilocybin (20 mg), 1 x MDMA (100 mg), 1 x Psilocybin (20 mg) + MDMA (100 mg), and 1 x Placebo with an interval of at least 10 days. The order of substance administration is randomly determined. Each morning of the study, an intravenous catheter will be placed in the elbow. You will be connected to this venous catheter throughout the day. Measurements during the substance effects (including blood draws, blood pressure, pulse, and questionnaires) will occur in the first half of the day every 30 minutes and in the second half of the day every 60 minutes. You will spend the entire day in a quiet room equipped with a bed at the outpatient study center of the University Hospital of Basel. The experience can be intensified by slightly darkening the room and listening to music. You will be continuously monitored throughout the study day.
(BASEC)
Untersuchte Intervention
In the context of the study, you will receive 1 x Psilocybin (20 mg), 1 x MDMA (100 mg), 1 x Psilocybin + MDMA (20 mg and 100 mg), and 1 x Placebo with an interval of at least 10 days.
(BASEC)
Untersuchte Krankheit(en)
Healthy subjects
(BASEC)
- Physically and mentally healthy - Aged between 25 and 65 years - BMI between 18-29 (BASEC)
Ausschlusskriterien
- Excessive substance use (including medications, nicotine, and alcohol) - Hypertension - Recent participation in another clinical study (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
Matthias Liechti
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Matthias Liechti
061 328 68 68
matthias.liechti@clutterusb.chUniversitätsspital Basel
(BASEC)
Allgemeine Auskünfte
University Hospital Basel, Basel, Switzerland
+41 61 328 68 68+421 61 328 68 68
matthias.liechti@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
13.06.2024
(BASEC)
ICTRP Studien-ID
NCT06884514 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Acute effects of MDMA co-administration on the response to psilocybin in healthy subjects (BASEC)
Wissenschaftlicher Titel
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (ICTRP)
Öffentlicher Titel
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (ICTRP)
Untersuchte Krankheit(en)
Healthy (ICTRP)
Untersuchte Intervention
Drug: PsilocybinDrug: 3,4-MethylenedioxymethamphetamineDrug: Psilocybin placeboDrug: 3,4-Methylenedioxymethamphetamine placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
1. Age between 25 and 65 years.
2. Understanding of the German language.
3. Understanding the procedures and the risks that are associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances
during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black
or green tea, or energy drink after midnight of the evening before the study
session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines
within 48 h after substance administration.
8. Willing to use effective birth control throughout study participation.
9. Body mass index between 18-29 kg/m2.
Exclusion Criteria:
1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder
3. Psychotic disorder in first-degree relatives, not including psychotic disorders
secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of
the brain.
4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
5. Illicit substance use (not including cannabis) more than 20 times or any time within
the previous month
6. Pregnant or nursing women.
7. Participation in another clinical trial (currently or within the last 30 days).
8. Use of medications that may interfere with the effects of the study medications.
9. Tobacco smoking (>10 cigarettes/day).
10. Consumption of alcoholic drinks (>15 drinks/week). (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Acute Subjective effects I;Acute Subjective effects II;Acute Subjective effects III;Acute autonomic effects I (blood pressure);Acute autonomic effects I (heart rate);Acute autonomic effects III (body temperature);Acute autonomic effects IV (ECG QT-time) (ICTRP)
Peak plasma concentration (Cmax) of MDMA and metabolites;Time to peak plasma concentration (Tmax) of MDMA and metabolites;Area under the plasma concentration vs. time curve (AUC) of MDMA and metabolites;Elimination half-life values of MDMA and metabolites;Peak plasma concentration (Cmax) of Psilocybin and metabolites;Time to peak plasma concentration (Tmax) of Psilocybin and metabolites;Area under the concentration vs. time curve (AUC) of Psilocybin and metabolites;Elimination half-life values of Psilocybin and metabolites;Plasma concentration of Oxytocin;States of Consciousness Questionnaire;Spiritual Realms Questionnaire;Subacute effects on general and mental well-being I (WEMWBS);Subacute effects on general and mental well-being II (GHQ-12);Subacute effects on general and mental well-being III (SPANE);Subacute effects on general and mental well-being IV (BFW/E);Subacute effects on general and mental well-being V (GLS);Adverse effects (acute and subacute);Effects on Appreciation;Effect moderation by personality traits I (NEO-FFI);Effect moderation by personality traits II (FPI-R);Effect moderation by personality traits III (SPF);Effect moderation by personality traits IV (HEXACO);Effect moderation by personality traits V (DSQ-40) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Matthias E Liechti, Prof. Dr. MDMatthias E Liechti, Prof. Dr. MDMatthias E Liechti, Prof. Dr. MD, matthias.liechti@usb.chmatthias.liechti@usb.ch, +41 61 328 68 68+421 61 328 68 68, University Hospital Basel, Basel, Switzerland (ICTRP)
Sekundäre IDs
BASEC 2024-00893 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06884514 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar