Sub(acute) Profiling of 2C-B Versus Psilocybi

• Conditions: /A

• Registration Number: NL-OMON28125
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Previous experience with at least one psychedelic substance (e.g., psilocybin, LSD, DMT,
ayahuasca, psilocybe fungi =1 times) but not within the past three months.
2. Aged between 18 and 40 years.
3. Free from medication (any drug prescribed for a medical indication).
4. The participant is, in the opinion of the investigator, generally healthy based on assessment of
medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the
haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
5. A resting pulse and heart rate (as read on the ECG) =51 bpm and =100 bpm. For participants in
good physical condition, the lower limit is =45 bpm.
6. A resting systolic blood pressure =91 mmHg and =140 mmHg and a resting diastolic blood
pressure =51 mmHg and =90 mmHg.
7. Clinical laboratory test values within clinical reference ranges at screening. Borderline values
may be accepted if they are, in the opinion of the investigator, clinically insignificant.
8. Normal binocular visual acuity, corrected or uncorrected.
9. Absence of any major medical, endocrine and neurological condition, as determined by the
medical history, medical examination, electrocardiogram and laboratory analyses (haematology,
clinical chemistry, urinalysis, serology).
10. Normal weight, body mass index.
11. Written informed consent.

Exclusion Criteria

1. Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks).
2. Use of medication (other than paracetamol).
3. History of drug addiction (determined by the medical questionnaire, drug questionnaire and
medical examination).
4. Excessive alcohol consumption (>20 units a week).
5. Excessive smoking (>20 cigarettes a week).
6. Current or history of psychiatric disorder (determined by the medical questionnaire and
medical examination).
7. Hypertension (diastolic >90 mmHg; systolic >140 mmHg).
8. Liver dysfunction (hepatitis, cirrhosis, cancer, biliary cholangitis, hemochromatosis, alcoholic
liver disease, etc as determined by the medical examination).
10. Renal insufficiency (as indicated by the medical examination).
11. History of cardiac dysfunctions (arrhythmia, ischemic heart disease, etc).
12. Pregnancy or lactation.
13. For women: absence of reliable contraceptive measures.
14. fMRI contraindications (pacemakers, metal implants, claustrophobia, permanent eye makeup).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute dosing day performance as assessed by the digit symbol substitution task.