Clinical TrialNeuroimaging & Brain Measures2C-XPsilocybinPlaceboCompleted

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

This interventional study, named PREDICT and conducted by Maastricht University, aims to comprehensively evaluate the acute and subacute effects of 2C-B compared to psilocybin and a placebo.

Target Enrollment
18 participants
Study Type
interventional
Design
Randomized, double Blind
Registry
NTR / NL8813

Detailed Description

Randomised, double-blind, three-condition crossover in healthy volunteers (n=18) comparing single oral 20 mg 2C-B, 15 mg psilocybin and a 200 ml bitter lemon placebo; sessions separated by a two-week washout and each dosing day lasts ~6 hours.

Outcomes include acute cognitive and behavioural tasks, resting-state fMRI and MRS, intensive pharmacokinetics/metabolomics sampling, hourly subjective-effect ratings, and subacute follow-ups at 24 h and 5 days to profile persisting effects.

Study Protocol

Preparation

sessions

Dosing

3 sessions
360 min each

Integration

sessions

Study Arms & Interventions

2C-B 20 mg

experimental

Single oral 20 mg 2C-B solution; part of 3-way randomised crossover.

Interventions

  • 2C-X20 mg
    via Oral• single dose

    Powder dissolved in bitter lemon drink.

Psilocybin 15 mg

active comparator

Single oral 15 mg psilocybin solution; part of 3-way randomised crossover.

Interventions

  • Psilocybin15 mg
    via Oral• single dose

    Powder dissolved in bitter lemon drink.

Placebo (bitter lemon)

inactive

200 ml bitter lemon drink (non-active control) administered as vehicle; part of 3-way crossover.

Interventions

  • Placebo200 ml
    via Oral• single dose

    Non-active control (bitter lemon drink).

Participants

Ages
18 – 40
Sexes
Male & Female

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).
  • 9. Renal insufficiency (as indicated by the medical examination).
  • 10. History of cardiac dysfunctions (arrhythmia, ischemic heart disease, etc).
  • 11. Pregnancy or lactation.
  • 12. For women: absence of reliable contraceptive measures.
  • 13. fMRI contraindications (pacemakers, metal implants, claustrophobia, permanent eye makeup).

Study Details

Locations

Netherlands

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