Co-administration of Psilocybin and MDMA in healthy individuals

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT06884514 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Acute effects of MDMA co-administration on the response to psilocybin in healthy subjects (BASEC)

Titre académique
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (ICTRP)

Titre public
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (ICTRP)

Maladie en cours d'investigation
Healthy (ICTRP)

Intervention étudiée
Drug: PsilocybinDrug: 3,4-MethylenedioxymethamphetamineDrug: Psilocybin placeboDrug: 3,4-Methylenedioxymethamphetamine placebo (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)

Critères d'inclusion/exclusion
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)

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Critères d'évaluation principaux et secondaires
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)

Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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)

ID secondaires
BASEC 2024-00893 (ICTRP)

Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06884514 (ICTRP)