Fibromyalgia
Conditions
Interventions
This study was designed to determine the dose-response relationship of the administration of a standardized solution containing cannabidiol and tetrahydrocannabinol in a 1 by 1 ratio to treat fibromya
Sponsors
FG Brasil LTDA
3F Clinical Trials LTDA
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the dose-response curve and median effctive dose (ED50) in relation to the change in pain intensity within the dose range determined in this study, compared to placebo, as measured by the McGill Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness in reducing fibromyalgia symptoms through reduction of pain catastrophizing: by the Pain Catastrophic Scale (B-PCS); Improvement of acceptance and daily action in relation to pain: by the Acceptance and Action Questionnaire-II (QAA-II); Improvement in depressive symptoms: data from the Beck Depression Inventory and the Hamilton Depression Rating Scale; Change in sleep quality: Subjective domain of sleep quality using the Pittsburgh Sleep Quality Index; Change in sleep duration: PSQI, sleep duration domain; Absence of daytime sleepiness: according to the Epworth sleepiness scale; Insomnia reduction: by the Insomnia Severity Index; Increase in quality of life: using the Fibromyalgia Impact Questionnaire (FIQ). | — |
Countries
Brazil
Contacts
Public Contact3F Clinical Trials LTDA.
fg brasil ltda
Outcome results
None listed