Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study (NCT07362407) | Clinical Trial Compass
By InvitationNot Applicable
Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study
Brazil384 participantsStarted 2026-03-01
Plain-language summary
What is the purpose of this study? The use of medicinal cannabis has grown significantly in Brazil. However, because many patients use these products through "compassionate use" (when traditional treatments haven't worked), there is still a lack of large-scale data on how these treatments perform in daily life. This study, called CANAREAL, aims to track patients across Brazil to understand if cannabis-based products are truly effective and safe for treating various conditions, such as chronic pain, anxiety, and depression.
How will the study work? This is an observational study, which means the researchers will not provide the medication or change the treatment prescribed by the patient's doctor. Instead, we will simply "follow" the patient's journey for 6 months.
What will participants be asked to do? Participants will complete online questionnaires at different stages of their treatment. These tools will measure:
Quality of Life: How the treatment affects daily well-being.
Clinical Evolution: Changes in pain levels, anxiety, and depression symptoms.
Safety: Whether the patient experiences any side effects (adverse events).
Why is this study important? Unlike controlled laboratory tests, this "Real-World Study" captures the reality of diverse patients with different backgrounds and health needs. The information gathered will help doctors, patients, and health authorities in Brazil better understand the benefits and risks of cannabinoid therapy, leading to safer and more informed medical decisions in the future.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years or older.
* Residents of Brazil.
* Patients who have a valid medical prescription for cannabis-based products.
* Patients who are either starting a new treatment or are already using cannabinoid products under the ANVISA RDC 660/22 or RDC 327/19 regulations.
* Capability to understand and sign the Informed Consent Form (ICF).
* Access to a smartphone or computer with internet to complete the digital follow-up questionnaires.
Exclusion Criteria:
* Patients who do not agree to the terms of the Informed Consent Form (ICF).
* Patients who fail to complete the initial (Baseline/T0) sociodemographic and clinical questionnaires.
* Inability to communicate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is 'enrolling by invitation only' — can you tell me whether I might be eligible to be referred or invited to participate, and who controls that invitation process?
2Since this is a real-world observational study measuring changes in quality of life with cannabinoid treatments like CBD, does taking part mean I'd actually receive a cannabinoid treatment, or would I just be tracked based on what I'm already taking?
3Given that this study has no assigned phase, meaning it isn't a traditional drug trial testing safety or efficacy in a controlled way, how confident can we be about what the results will actually tell us about whether cannabinoids are safe and effective for my chronic pain, depression, or anxiety?
4Are there standard treatments for my condition — like established medications or therapies — that we should try or continue alongside any cannabinoid use, rather than waiting to see what this observational study shows?
5If I were to participate, what would my practical involvement look like — how often would I need to report quality-of-life data, and could the demands of the study realistically fit with my current health situation and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.