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

Study Rationale and Context The CANAREAL study is designed as a prospective, longitudinal, observational investigation aimed at filling the gap between controlled clinical trials and the clinical reality of medicinal cannabis use in Brazil. Under current Brazilian regulations (RDC 327/2019 and RDC 660/2022), patients access cannabinoid-based products primarily through compassionate use. This study adopts a Real-World Evidence (RWE) approach to evaluate how these treatments perform across a heterogeneous population with various comorbidities and treatment regimens.

Study Design and Procedures Participants who have already been prescribed cannabis-based products by their physicians will be recruited. The study does not interfere with medical prescriptions, dosages, or product choices.

Data collection will be conducted at three specific time points over a 180-day (6-month) period:

Baseline (T0): Collection of demographic data, medical history, primary reason for cannabis use, and previous conventional treatments. Initial scores for pain, anxiety, depression, and quality of life will be recorded.

Intermediate Follow-up (T1 - 90 days): Assessment of clinical evolution and monitoring of any early adverse events.

Final Assessment (T2 - 180 days): Final evaluation of therapeutic efficacy and overall impact on the patient's quality of life.

Instruments and Measurements To ensure objective quantification of subjective symptoms, the following validated psychometric and clinical tools will be utilized:

Quality of Life: The WHOQOL-Bref (World Health Organization Quality of Life) and EUROQOL-5D scales.

Clinical Symptomatology: The Visual Analogue Scale (VAS) for pain intensity, the Beck Depression Inventory (BDI), and the Beck Anxiety Inventory (BAI).

Safety Profile: The UKU Side Effect Rating Scale will be used to document the frequency, severity, and nature of adverse drug reactions (ADRs).

Data Management and Analysis Data will be collected via secure digital platforms (Google Forms/WhatsApp). Statistical analysis will include descriptive statistics for demographic characterization and inferential analysis (e.g., paired t-tests or non-parametric equivalents) to compare baseline scores against the 3-month and 6-month follow-ups. The study intends to identify patterns of efficacy based on the cannabinoid profile (CBD-dominant, THC-dominant, or balanced) and the specific medical conditions treated.

Ethical Compliance The study is conducted in accordance with the Declaration of Helsinki and submitted for approval by the Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC). All participants must provide electronic Informed Consent (ICF) before data collection begins.

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.