RBR-4bhmm7yNot yet recruitingPhase 2
CBD/THC solution as a pharmacological strategy for patients with fibromyalgia: single-center, double-blind, randomized, placebo controlled clinical trial protocol (FibroCann) - FibroCann - Fibromyalgia, Cannabinoid
FG Brasil LTDA0 sitesStarted: February 23, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Intervention
Eligibility Criteria
- Ages
- 18Y to 75Y (—)
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Investigators
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