Study on Psilocybin and Midazolam for Reducing Atherosclerosis in Patients with Coronary Artery Disease

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Ischemic Heart Disease, a condition where the heart’s blood supply is reduced due to narrowed arteries. The study will explore the use of two different treatments: Psilocybin, a compound known for its potential psychological effects, and Midazolam, a medication often used for its calming effects. Both treatments will be administered in the form of hard capsules taken orally.

The purpose of the study is to investigate whether these treatments can help reduce the buildup of fatty deposits, known as atherosclerotic plaques, in the arteries of the heart. Participants will receive either psilocybin-assisted psychotherapy or midazolam-assisted psychotherapy. The study will last for 12 months, during which participants will undergo regular heart examinations to monitor changes in plaque volume. The researchers hope to see a reduction in plaque volume, which could improve heart health.

Throughout the study, participants will be monitored using various techniques, including Optical Coherence Tomography (OCT), a method that provides detailed images of the heart’s arteries. The study aims to understand how these treatments might influence the composition of the plaques and potentially reduce the risk of heart-related complications. By the end of the study, the researchers hope to gather valuable information on the effectiveness of these treatments in managing ischemic heart disease.

1 enrollment

Eligibility is determined based on age (18-75 years), diagnosis of stable coronary artery disease, and other criteria.

Participants must agree to use prescribed contraceptive methods during the trial.

2 initial assessment

An initial coronary artery examination is conducted to assess atherosclerotic plaque volume.

This examination includes techniques such as selective coronarography and intravascular ultrasound.

3 medication administration

Participants are randomly assigned to receive either psilocybin or midazolam as part of psychotherapy.

Both medications are administered orally in the form of hard capsules.

4 psychotherapy sessions

Participants undergo psychotherapy sessions assisted by the assigned medication.

The aim is to reduce chronic stress and potentially influence plaque composition.

5 follow-up assessment

A follow-up coronary artery examination is performed 12 months after the initial assessment.

The examination evaluates changes in atherosclerotic plaque volume and composition.

6 data analysis

The primary endpoint is the evaluation of plaque volume reduction.

Secondary endpoints include changes in plaque composition and fibrous cap thickness.

Who Can Join the Study?

Men and women aged 18-75 can participate.
Participants must have a diagnosis of stable coronary artery disease. This means they have a condition affecting the heart’s blood vessels, and they have had a myocardial infarction (heart attack) at least 6 weeks before joining the study.
Participants must have a coronary finding of stenosis. This means there is a narrowing in one of the major heart arteries that is at least 2.5 mm wide, but the narrowing should not be more than 50% of the normal width of the artery. This artery should not have had any previous medical procedures.
Participants must be able to fully understand the study information and complete the study questionnaires.
Participants who can have children must agree to use prescribed contraceptive methods to prevent pregnancy while taking part in the study. This is important because the study involves medications that leave the body within 24 hours. Contraception should be used from the time of joining the study until three days after taking the study medication. For women, this includes methods like hormonal contraceptives, an intrauterine device (IUD), or sexual abstinence. For men, this includes using a condom or practicing sexual abstinence.

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who do not have Ischemic Heart Disease, which is a condition where the heart doesn’t get enough blood and oxygen.
Patients who are not able to undergo the required medical examinations for the study.
Patients who cannot follow the study’s treatment plan, which includes specific therapies.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to give informed consent, meaning they cannot understand and agree to the study’s requirements.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Peode sejqty	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	14.10.2024

Trial locations

Investigated drugs:

Psilocybin is a substance being studied for its potential to help reduce atherosclerotic plaque in patients with coronary artery disease. In this trial, it is used as part of a psychotherapy treatment. The goal is to see if this therapy can lead to a significant reduction in plaque volume, which could improve heart health.

Midazolam is used in this trial as a control treatment. It is a medication that can help with relaxation and anxiety, often used in medical settings. In this study, it is used to compare the effects of psilocybin-assisted psychotherapy, helping researchers understand the specific impact of psilocybin on atherosclerotic plaque regression.

Ischemic Heart Disease – Ischemic heart disease occurs when the heart muscle doesn’t receive enough blood and oxygen, usually due to narrowed or blocked coronary arteries. This condition often leads to chest pain, known as angina, especially during physical activity or stress. Over time, the reduced blood flow can weaken the heart muscle, potentially leading to heart failure. The disease progresses as atherosclerotic plaques build up in the coronary arteries, further restricting blood flow. Symptoms may include shortness of breath, fatigue, and palpitations. The progression of the disease can vary, with some individuals experiencing stable symptoms and others facing more severe complications.

Trial ID:

2024-517902-27-00

Protocol code:

RAFAEL

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Psilocybin and Midazolam for Reducing Atherosclerosis in Patients with Coronary Artery Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?