Regression of atherosclerosis induced by life changing experience with psilocybi
- Conditions
- Ischemic Heart DiseaseTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2022-003381-21-CZ
- Lead Sponsor
- Psyon, s.r.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1) Men and women aged 18-75
2) Diagnosis of stable coronary artery disease (I25.9) with a history of myocardial infarction at least 6 weeks before signing informed consent.
3) A coronary finding of stenosis on one of the major coronary arteries of at least 2.5 mm in diameter with narrowing that does not exceed 50 % of the reference diameter and is on the native artery without previous intervention.
4) Patient's cognitive ability to fully understand CH information and study questionnaires.
5) Participants of childbearing age/preserved fertility must agree to use prescribed contraceptive methods and avoid pregnancy while exposed to study medication in this clinical trial. Since both psilocybin and midazolam are eliminated from the body within 24 hours, we are setting the minimum duration of contraceptive use at an interval from enrolment to three days after study drug administration. The following methods of contraception are required:
(a) Females – we require proper use of at least a barrier contraceptive method (non-hormonal IUD and/or condom and/or vaginal pessary) or sexual abstinence. Hormonal contraception (combined hormonal contraception - in oral, vaginal or transdermal dosage form/ gestagen hormonal contraception combined with ovulation inhibition - in oral or injectable dosage form/ IUD) is not required but is accepted if the patient is already using)
b) Men - use of at least an adequate barrier contraceptive method (condom) or sexual abstinence.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1) Severe neurological disease of the CNS. In case of suspicion of such disease, the CNS imaging (CT/MR) must be negative.
2) Focal neurological findings
3) Inability to orally administer study medication in capsule form
4) Patient's condition does not allow compliance with concomitant therapy (see sections 6.5 and 6.6)
5) Known intolerance or allergy to psilocybin or midazolam.
6) Pregnancy or breastfeeding
7) Hepatic dysfunction with GGT, AST, ALT values > 5 times the upper limit of normal, total bilirubin > 50 µmol/l
8) Cardiovascular instability in the sense of uncorrected hypertension (baseline BP = 140/90 mm Hg - mean of 3 measurements), manifest heart failure NYHA II or more, left ventricular ejection fraction < 50%, history of ventricular tachycardia except reperfusion arrhythmias, atrial fibrillation with resting ventricular rate > 100/min (mean of 3 measurements)
9) Anatomical findings not allowing IVUS and OCT examination. I.e. tortuous coronary artery, markedly calcified stenosis
10) Status post aortocoronary bypass with a functional graft to the artery of interest
11) Prior myocardial infarction less than 6 weeks ago with full revascularization
12) Prior stroke and/or TIA less than 6 months ago
13) Clinically significant peripheral vascular disease (acute venous thrombosis, chronic venous insufficiency at the stage of tibial ulceration, lower extremity ischemic disease at the stage of defects)
14) Pulmonary disease with a reduction in vital capacity to 75% of appropriate values, or FEV 1 less than 1.5 l. Sleep apnoea syndrome
15) Severe thrombocytopenia < 50 x 109/l, resistant to replacement
16) Myasthenia gravis
17) Epilepsy including a history of isolated epileptic seizures
18) Renal insufficiency with creatinine clearance < 0.6 ml/s
19) Known paraneoplastic syndrome or ectopic hormone production by the primary tumour, which could include hypercalcemia, Cushing's syndrome, hypoglycaemia, SIADH, or carcinoid syndrome
20) Diabetes mellitus on insulin or corrected with oral antidiabetic agents if there is a history of clinically significant hypoglycaemia
21) Glaucoma
22) Untreated or incompletely compensated hyperthyroidism
23) Use of psilocybin or another serotonergic psychedelic in the past 12 months
24) Any current or history of psychotic illness from the diagnosis F2x.x
25) Any other serious psychiatric illness based on psychiatric examination
26) Stable treatment with antidepressants/thymostabilisers/antipsychotics in a non-hypnotic indication (doses must not be above the antidepressant, antipsychotic or thymostabilising levels as per SPC).
27) Presence of suicidal ideation/behavior based on the C-SSRS version of the Lifetime/Recent (L/R) (specifically, a yes response to question 5 in the past 1 month and/or any yes response to suicidal behavior questions in the past 3 months) and/or clinical examination
28) Current or history of alcohol or drug dependence F1x.x. unless at least 2 years of abstinence can be demonstrated
29) Other inappropriateness of the patient's classification based on the clinical judgment of the examining physician
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method