Healthy Male and Female Volunteers

Reimbursement: £1500 plus travel expenses or transport reimbursed

About This clinical research study

Are you aged 18 – 65 and in good health?

If so, you could be eligible to take part in this healthy volunteer clinical trial.

The purpose of this trial is to assess a potential new treatment for depression.

There is an unmet need for new and improved treatments to help those suffering from low mood and depression. Many people do not respond appropriately or suffer side-effects from current approved medications, which can result in patients not taking them.

The trial will assess ELE-101 (the study medication). ELE-101 is the active metabolite of psilocybin. Psilocybin is a controlled drug and a chemical compound found in some species of mushrooms. Recent studies have suggested that psilocybin may help in treating depression due to its action on the serotonin system in the brain which is linked to the regulation of mood.

Reimbursement: £1500 plus travel expenses or transport reimbursed

Clinics

Greater Manchester and Merseyside

Therapy Area

Healthy Volunteers

Gender and Age

Males and Females aged 18 - 65

A full description of the study will be given before you decide to take part, both over the phone and during an appointment at a MAC clinic. This will include you receiving the full Patient Information Sheet (PIS) and an opportunity to ask the study doctor any questions. Your GP will also be notified of your participation.

If you contact us, it does not mean you have to decide at that point whether to participate.
If you do decide to participate you are free to withdraw at any time.

The study will last for approx. 6 weeks, and you will be required to attend 1 x medical Screening, 1 x 2-night residential stay, 1 x follow up visit and receive 1 x phone call.

Reimbursement: £1500 plus travel expenses or transport reimbursed

Key Inclusion Criteria

Key Exclusion Criteria

Other eligibility criteria will apply. Please contact MAC for more information.

If you are eligible you will receive a comprehensive health screen. Your GP will be fully informed of your participation and provided with any information relevant to your healthcare.

ABOUT CLINICAL RESEARCH STUDIES

Clinical research studies are performed as a way of bringing about progress in medicine and research. Clinical research studies make it possible to scientifically assess the properties of a drug, to demonstrate the effectiveness and safety of a treatment or a medical device, or to learn more about a disease and methods to diagnose and monitor it.

If the study is successful, it may be an important step towards developing a promising new treatment.

MAC Clinical Research is currently conducting a new clinical research study for Male and Female Healthy Volunteers.

If you would like more information, please fill in the form below and we will be in touch…

Alternatively, please call our recruitment team on freephone 0800 633 5507.

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Frequently Asked Questions

Clinical trials are an essential part of medical research. They are performed as a way of bringing about progress in medicine. Clinical trials make it possible to scientifically assess the properties of a medicine, to demonstrate the effectiveness and safety of a treatment or a medical device, or to learn more about a disease and methods to diagnose and monitor it. The results of a clinical trial may help provide treatment options for people diagnosed with medical conditions.

It depends on the trial. Some trials require only people with certain diseases or conditions, or whose family members have certain diseases or conditions. Other trials can use people who are healthy. The National Institute for Health Research reported that 1.3 million people took part in clinical trials across England in 2021.

The first phase of a clinical trial (Phase I) requires healthy volunteers to test safety and tolerability aspect of an investigative medicine, rather than its efficacy in treating a disease. Phase I trials typically involve 10 – 200 participants.

If you are at least 18 years of age and in good health (determined by medical and psychiatric history, medical examination, ECG and blood tests), you may be eligible to take part.

There is no obligation to take part in a healthy volunteer trial and if you decide to, you are free to withdraw at any time. Healthy volunteers are needed so that new treatments can be researched in the hope they provide a better quality of life for people living with medical conditions. You may be able to make a difference to a medical condition that has personal meaning to you and there could be opportunities for you to work from the clinic and meet like-minded people during your visits.

Yes. Before a clinical trial commences, we must seek approval from an independent Ethics Committee that protects the rights, safety, and well-being of all clinical trial participants. The committee is made up of medical health professionals and members of the public. All MAC clinical trials meet the international standards of good practice set in place by the Medicines and Healthcare products Regulatory Agency (MHRA), a government body which monitors clinical trials in the UK.

You will not receive medical benefit whilst taking part in a healthy volunteer clinical trial. You will, however, be able to keep up to date on your health; MAC will provide a free, comprehensive medical screening.

All medications, even those as common as paracetamol and aspirin have possible side effects and have all gone through the clinical trial process. Only once a potential new medication has been through many years of stringent testing and ethical review will it be approved for study at a MAC clinic. Before you join a trial, our doctors will provide you with details of previously reported side effects. Full details will also be clearly explained in the participant information sheet. Typically, reported side effects are mild and affect only a small percentage of people. If you participate, you will be closely monitored by our experienced medical team and you will have regular check-ups to ensure your wellbeing. Your participation will be in collaboration with your GP, your medical records and medical history will be taken, and you will need to pass a medical screening before you can enrol. Your health is paramount and only if it is deemed safe for you to participate will you be offered the opportunity to.

You will be required to attend a MAC clinic for a set number of visits. Throughout the trial you will be well looked after by our medical professionals including doctors and nurses.

No. If you are accepted onto the clinical trial, we will cover the cost of reasonable travel expenses you may incur for clinic visits, or we will organise transportation for you if this is required. Meals will be provided on some day visits and all overnight stays.

Early phase clinical trials test the safety and tolerability of a treatment and require healthy volunteers attend day visits and sometimes overnight stays. These trials pay participants for their time and commitment. Please check the Current Trials page of our website.

Each clinical trial is different. The frequency and duration of the visits will vary, and our telephone agents will advise you of day visits or overnight stays and the length of trial before you decide whether you would like to take part.

We will do our best to work clinic visits around your availability however clinical trials have procedures that must be conducted on specific days of the trial.

Yes. We will request your medical records from your GP, with your consent to check your eligibility to participate. If you pass your medical screening and decide to join the study, we will contact your GP to tell them that you are taking part. During the course of the study, we will keep your GP informed of any significant findings.

Yes. Participation in our clinical trials is voluntary. If you change your mind and no longer wish to take part, you are welcome to withdraw at any stage without giving a reason. If you do consider withdrawing from a trial, the decision you make will be respected.

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