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

NCT07362407 | Enrolling By Invitation FDA Drug

• 2 other identifiers: CANAREAL-20258.083.335
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Depression Disorders; Anxiety Disorders; Quality of Life; Cannabidiol Effects; Cannabinoids

Keywords

cannabis; cannabinoids; medical cannabis; Real-Word Evidence; Quality of life; observational study; cbd; thc; brazil; chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life Scores

  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 Outcomes (3)

• 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.

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  From Day 45 through Month 6.

Study Arms (1)

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.

Interventions

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

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.

Also known as: Cannabis-based products, Phytocannabinoids, CBD oil, medical marijuana, Full-spectrum

Medicinal Cannabinoid Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santa Catarina Federal University: lead
• HempMeds Brasil: collaborator

Study Sites (1)

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

Florianópolis, Santa Catarina, 88049-900, Brazil

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Anxiety Disorders; Marijuana Abuse; Color Vision Defects; Wiskott-Aldrich Syndrome

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Vision Disorders; Sensation Disorders; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphopenia; Leukopenia; Cytopenia; Hemorrhagic Disorders; Leukocyte Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

BR (1)