CBD/THC solution as a pharmacological strategy for patients with fibromyalgia (FibroCann)
- Conditions
- Fibromyalgia
- Registration Number
- RBR-4bhmm7y
- Lead Sponsor
- FG Brasil LTDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Previous diagnosis of fibromyalgia based on the pharmacological criteria of the American College of Rheumatology, 2016 to fibromyalgia, having received three months of pharmacological treatment without relevant clinical improvement; Adult individuals (aged 18 to 75 years) with a mean pain intensity greater than or equal to 7 on the FIQ numerical pain scale (Fibromyalgia Impact Questionnaire); No use of Cannabis or its derivatives (THC and CBD) in any systemic administration route in the last six months; Capability to read, write and speak in Portuguese (Brazil); Sign the ICF (Informed Consent Form).
Pregnancy or breastfeeding; Any known pathology, in an advanced stage, associated with the locomotor system (arthritis, osteoarthritis, uric acid); Neurological disorders; Previously reported renal disorders or changes in the exams during the pre-randomization stage; Previously reported liver disorders or changes in tests during the pre-randomization stage; Peripheral neuropathy; Known serious cardiovascular disease (uncontrolled hypertension, heart failure, cardiac pacemaker); Medical decision that participation in the study is not in the best interest of the patient; Making previous use of cannabinoids by any route of administration; Diagnosis of alcohol dependence; Usage of psychotomimetic drugs or narcotics; Having participated in research projects in the two months prior to the beginning of the study; Having a history or having first-degree relatives with a history of psychosis in any level at least once in their lifetime; Inappropriate metabolic profile of THC or CBD cannabinoids for the use of the test doses in this study, observed by pharmacogenetic testing.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method