Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study (CANAREAL)
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Santa Catarina Federal University
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- Change in Quality of Life Scores
Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Medicinal Cannabinoid Users
Patients who use or are starting treatment with cannabis-based products prescribed under Brazilian regulations (RDC 660/22). This group includes individuals seeking treatment for various clinical conditions, such as chronic pain, anxiety, and depression, through compassionate use.
Intervention: 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. (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Quality of Life Scores
Time Frame: 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.
Secondary Outcomes
- Change in Pain Intensity(Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.)
- Change in Depression Severity(Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.)
- Change in Anxiety Severity(Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.)
Investigators
Taynara da Silva
Principal Investigator
Santa Catarina Federal University