drug effects, drug metabolites Not applicable
Conditions
Interventions
20mg 2C-B, 15 mg Psilocybin, placebo (bitter lemon soft drink )
Each to be administered orally, dissolved as a solution in bitter lemon soft
drink.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 =45 bpm. • A resting systolic blood pressure >=91 mmHg and =51 mmHg and
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Acute Digit Symbol Substitution Task performance (DSST) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Acute fMRI cognitive reappraisal task performance and fMRI activation -Acute embodiment reality task and questionnaire performance - Subjective effect questionnaires scores - Neurocognitive task performance - fMRI resting state functional connectivity - Magnetic resonance spectroscopy neurotransmitter concentrations and metabolic activity - Plasma metabolomics (steroid hormones, neurotransmitters, endocannabinoids, drug metabolitex) concentrations - Plasma and ear-wax drug kinetics - Subacute and prepost persisting effect questionnaires scores - Subacute and prepost behavioural task performance | — |
Countries
Netherlands
Outcome results
None listed