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

March 25, 2026 updated by: Taynara da Silva, Santa Catarina Federal University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88049-900
        • Universidade Federal de Santa Catarina (UFSC), Centro de Ciências Biológicas (CCB), Campus Universitário, Trindade, Florianópolis - SC.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study targets a diverse population of patients in Brazil who seek cannabinoid therapy for various medical conditions, primarily chronic pain, anxiety, and depression, through the pharmaceutical and clinical service flow of partner companies and clinics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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 validated scales over a 6-month period.
Other Names:
  • CBD oil
  • medical marijuana
  • Cannabis-based products
  • Phytocannabinoids
  • Full-spectrum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.
Assessment of pain using the Visual Analogue Scale (VAS). Patients report their pain level on a scale from 0 (no pain) to 10 (worst possible pain).
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.
Measured by the Beck Depression Inventory (BDI). It consists of 21 items. Total scores range from 0 to 63, with higher scores indicating increased severity of depressive symptoms.
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.
Measured by the Beck Anxiety Inventory (BAI). It consists of 21 items. Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Baseline, 45 days, 75 days, 105 days, 135 days, and 180 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: From Day 45 through Month 6.
Evaluation of side effects using the UKU Side Effect Rating Scale. This scale monitors psychic, neurological, autonomic, and other side effects. It will be used to document the safety profile of the cannabinoid products.
From Day 45 through Month 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Catarina Federal University

Collaborators

HempMeds Brasil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CANAREAL-2025
  • 8.083.335 (Other Identifier: Ethics Committee in Research of the Federal University of Santa Catarina)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) collected during the study will be shared in a de-identified format.

Data access will be granted to researchers whose proposed use of the data has been formally approved by an independent review committee.

The sharing process strictly complies with the Brazilian General Data Protection Law (LGPD).

De-identified raw data concerning quality of life scores obtained through WHOQOL-Bref and EUROQOL-5D instruments. Clinical evolution scores for pain (Visual Analogue Scale - VAS), anxiety (Beck Anxiety Inventory - BAI), and depression (Beck Depression Inventory - BDI). Reported adverse events collected via the UKU Side Effect Rating Scale.

IPD Sharing Time Frame

Data will be available starting 6 months after the publication of the final study results.

Data availability will end 36 months after publication.

IPD Sharing Access Criteria

Data will be shared through a secure file transfer or via the Zenodo repository using the de-identification standards already planned to ensure participant confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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