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

Official title

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

Overview

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.

Interventions

• Dietary supplement 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 validat

Primary outcome measures

• Change in Quality of Life Scores [Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.]

Secondary outcome measures (3)

• Change in Pain Intensity [Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.]
• Change in Depression Severity [Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.]
• Change in Anxiety Severity [Time frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Brazil · 1 center

• Universidade Federal de Santa Catarina (UFSC), Centro de Ciências Biológicas (CCB), Campus — Florianópolis

Publications

• Pertwee RG. The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin. Br J Pharmacol. 2008 Jan;153(2):199-215. doi: 10.1038/sj.bjp.0707442. Epub 2007 Sep 10. PMID 17828291
• Cristino L, Bisogno T, Di Marzo V. Cannabinoids and the expanded endocannabinoid system in neurological disorders. Nat Rev Neurol. 2020 Jan;16(1):9-29. doi: 10.1038/s41582-019-0284-z. Epub 2019 Dec 12. PMID 31831863
• Maccarrone M, Di Marzo V, Gertsch J, Grether U, Howlett AC, Hua T, Makriyannis A, Piomelli D, Ueda N, van der Stelt M. Goods and Bads of the Endocannabinoid System as a Therapeutic Target: Lessons Learned after 30 Years. Pharmacol Rev. 2023 Sep;75(5):885-958. doi: 10.1124/pharmrev.122.000600. Epub 2023 May 10. PMID 37164640
• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9. PMID 3785962
• Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese. PMID 10881154
• Bhatt A. Conducting real-world evidence studies in India. Perspect Clin Res. 2019 Apr-Jun;10(2):51-56. doi: 10.4103/picr.PICR_8_19. PMID 31008069
• Kim HS, Lee S, Kim JH. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci. 2018 Jun 26;33(34):e213. doi: 10.3346/jkms.2018.33.e213. eCollection 2018 Aug 20. PMID 30127705
• Chodankar D. Introduction to real-world evidence studies. Perspect Clin Res. 2021 Jul-Sep;12(3):171-174. doi: 10.4103/picr.picr_62_21. Epub 2021 Jul 7. No abstract available. PMID 34386383

Identifiers

NCT: NCT07362407 · CANAREAL-2025 · 8.083.335

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗