Cannabis
Patients will receive the cannabis-based product in the following CBD:THC doses: 50:10mg/day,75:15mg/day, 100:20mg/day, or 125:25mg/day.
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The Fridinha Project is a pilot, multicenter, open-label clinical trial that will investigate the therapeutic effects of different CBD and THC dosages in modulating fibromyalgia, a syndrome characterized by widespread chronic pain, fatigue, sleep disturbances, and cognitive impairment. This condition primarily affects women between the ages of 34 and 60, and conventional treatment has shown limited efficacy and significant side effects. Given this scenario, the project proposes the use of cannabinoids extracted from Cannabis sativa to modulate fibromyalgia symptoms, leveraging their analgesic, anti-inflammatory, and neuroprotective properties. The study is based on the hypothesis that the administration of phytocannabinoids may reduce fibromyalgia symptoms and improve patients' quality of life. To achieve this, the protocol includes dose titration, starting with a CBD:THC concentration of 50:10 mg/day, with the possibility of gradual adjustment up to 125:25 mg/day, depending on clinical response. The experimental design includes patient follow-up at seven different time points over six months (T0 to T180). At T0, sociodemographic data will be collected, and several assessments will be conducted, including the Fibromyalgia Impact Questionnaire - Revised, Beck Depression Inventory, Pittsburgh Sleep Quality Index, Short Form-36, Epworth Sleepiness Scale, Beck Hopelessness Scale, NOVA Score, and the UKU Side Effects Rating Scale. Additionally, laboratory tests and polysomnography will be performed. In the subsequent follow-ups (T30, T60, T90, T120, T150, and T180), reassessments of clinical parameters will be conducted, with adjustments to the experimental product dosage as needed. Participant selection will include cisgender women with a confirmed diagnosis of fibromyalgia (according to the American College of Rheumatology criteria), while excluding cases with conditions that could interfere with treatment safety or evaluation, such as pregnancy, recent cannabinoid use, or severe cardiovascular diseases. In summary, the Fridinha Project aims to provide a cannabinoid-based therapeutic alternative for fibromyalgia management, intending to reduce the adverse effects of conventional treatments and significantly improve patients' quality of life. The results are expected to provide a scientific foundation for larger-scale research and support the development of public health policies to expand access to cannabis-based treatments within the Brazilian healthcare system.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-03-27
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Patients will receive the cannabis-based product in the following CBD:THC doses: 50:10mg/day,75:15mg/day, 100:20mg/day, or 125:25mg/day.
Eligibility
primary outcomes
Time frame: 6 months
It is a 21-item multiple-choice questionnaire that can be self-administered or administered by a researcher. This instrument aims to measure the impact of fibromyalgia on functional capacity, professional situation, psychological disorders, and physical symptoms. Its score is directly proportional to the impact of this pathology on quality of life and daily functioning, that is, the higher the score obtained, the worse the quality of life and the more compromised the patient's functioning.The score is: 0 good - 100 very bad
secondary outcomes
Time frame: 6 months
A questionnaire consisting of 10 varied open-ended and multiple-choice questions that can be self-administered or administered by a researcher, aims to measure sleep quality and disorders. Its score is tabulated as follows: 0-4 good sleep quality, 4-10 poor sleep quality, and \>10 presence of sleep disorder. This instrument will be applied at times T0 to T180.
Time frame: 6 months
A 36-item multiple-choice questionnaire that can be self-administered or administered by a researcher. Its main objective is to measure the impact of a certain pathology on the patient's quality of life, assessing both positive and negative aspects of health. It is scored in eight functional domains, which cannot be added together or averaged, with results ranging from 0 (worst quality of life) to 100 (best quality of life)
Time frame: 6 months
A 48-item multiple-choice questionnaire to be administered by a researcher aims to create a method for accessing and understanding the impact of adverse effects during pharmacological treatment. Its score is directly proportional to the impact of the pathology on the patient's quality of life and daily functioning.The score is: 0 good - 144 very bad
Time frame: 6 month
An 8-item questionnaire with dichotomous responses (yes/no), which can be self-administered or administered by a researcher, used to screen for risk of obstructive sleep apnea. Scoring is done by assigning 1 point for each "yes" answer, with a total score ranging from 0 to 8. Scores from 0 to 2 indicate low risk, from 3 to 4 indicate intermediate risk, and scores equal to or greater than five indicate high risk for apnea. The identification of patients with this disorder is essential in studies with medications that promote sleep, as these drugs can aggravate apnea and increase the risk of adverse events
Time frame: 6 months
A 17-item questionnaire that investigates whether there has been exposure to potentially traumatic events and how this occurred throughout life, in this sense, classifying the experience for each item as direct, witnessing, knowledge from third parties, or occupational exposure-in order to allow for different forms of contact for the same stressful event.This questionnaire is scored based on the sum of the items marked, with each item equivalent to 1 point. In addition, information can be extracted from the domains of accidental/injury trauma (items 1, 2, 3, 4, and 12), victimization trauma (items 6, 8, and 9), and predominant life-threatening trauma (items 5,7, 10, 11, 13, 14, 15, and 16). The score is: 0-68, higher scores = greater exposure to traumatic events.
Time frame: 6 months
It is a brief self-administered screening questionnaire composed of 6 yes/no items. This instrument is designed to help identify patients who may have fibromyalgia among individuals presenting with chronic widespread pain. The questions assess characteristic symptoms of fibromyalgia, such as diffuse pain, fatigue, sleep disturbances, and sensitivity to stimuli. The score corresponds to the number of positive responses, with higher scores indicating a greater likelihood of fibromyalgia.
Publications
No exact PMID-linked public article is currently readable locally.