Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Participants are followed while using cannabis-based products (such as CBD or THC oils, extracts, or isolates) as prescribed by their own physicians for therapeutic purposes.: This is an observational study of patients using cannabis-based products as prescribed by their personal physicians. The investigators do not provide, prescribe, or assign any medication. Participants will use various formulations (such as CBD-dominant, THC-dominant, or balanced full-spectrum oils) administered according to their specific medical guidance. Data collection will focus on the natural course of the treatment, monitoring clinical evolution, quality of life, and safety through validated scales over a 6-month period.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Quality of Life Scores — Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
  Evaluation of the patient's quality of life using the WHOQOL-Bref questionnaire (World Health Organization Quality of Life). This scale evaluates physical, psychological, social relationships, and environment domains. Scores range from 0 to 100, where higher scores indicate a better quality of life.

Trial sites (1)

Other trials for the same condition