EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA)

EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA)

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.

Inclusion Criteria:

I. Have a medical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria[29]; II. Be cisgender women; III. Be literate; IV. Be aged between 18 and 60; V. Score ≥ 5 points on the Fibromyalgia Rapid Screening Tool (FIRST); VI. Reside in the state of Paraná, Brazil.

Exclusion Criteria:

I. Not being available on a monthly basis to attend in person at the center that has been accredited to carry out follow-up consultations; II. Being pregnant or breastfeeding; III. Having secondary fibromyalgia (fibromyalgia associated with rheumatoid arthritis, systemic lupus erythematosus, or autoimmune disease); IV. Being at risk for sleep apnea (≥5 points on the STOP-Bang Questionnaire); V. Having advanced musculoskeletal disorders; VI. Having severe neuropathies and/or known severe cardiovascular diseases, such as stroke, acute coronary syndrome, cardiac arrhythmias, and myocardial infarction; VII. Having a diagnosis of bipolar disorder, or having first-degree relatives VII. Have a diagnosis of bipolar disorder, or have first-degree relatives diagnosed with psychosis and schizophrenia; VIII. Reported previous use of cannabinoids by any route of administration in the last 30 days; IX. Use of clobazam and/or sympathomimetic and anticholinergic medications; X. Diagnosis of alcohol dependence or opioid use; XI. Women who do not agree to sign the informed consent form.