Sub(acute) Neuropsychopharmacological Profiling of 2C-B vs Psilocybin

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

• 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
• Aged between 18 and 40 years
• Free from medication (any drug prescribed for a medical indication)
• 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
• 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.
• A resting systolic blood pressure >=91 mmHg and <=140 mmHg and a resting
diastolic blood pressure >=51 mmHg and <=90 mmHg.
• 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.
• Normal binocular visual acuity, corrected or uncorrected
• 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).
• Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2
• Written informed consent

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Acute Digit Symbol Substitution Task performance (DSST)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Acute fMRI cognitive reappraisal task performance and fMRI activation<br /><br>-Acute embodiment reality task and questionnaire performance<br /><br>- Subjective effect questionnaires scores<br /><br>- Neurocognitive task performance<br /><br>- fMRI resting state functional connectivity<br /><br>- Magnetic resonance spectroscopy neurotransmitter concentrations and metabolic<br /><br>activity<br /><br>- Plasma metabolomics (steroid hormones, neurotransmitters, endocannabinoids,<br /><br>drug metabolitex) concentrations<br /><br>- Plasma and ear-wax drug kinetics<br /><br>- Subacute and prepost persisting effect questionnaires scores<br /><br>- Subacute and prepost behavioural task performance </p><br>