Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study (CANAREAL)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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)
结局指标
主要结局
Change in Quality of Life Scores
时间窗: 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.
次要结局
- 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.)
研究者
Taynara da Silva
Principal Investigator
Santa Catarina Federal University