Status:
UNKNOWN
CBD (Cannabidiol)/THC (Tetrahydrocannabinol) Solution as a Pharmacological Strategy for Patients With Fibromyalgia (FibroCann)
Lead Sponsor:
FG Brasil LTDA
Collaborating Sponsors:
3F Clinical Trials LTDA
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Fibromyalgia is considered a chronic pain syndrome, non-inflammatory, of unknown etiology, which manifests itself in the musculoskeletal system in up to 2.5% of the general population, predominantly i...
Detailed Description
Patients with fibromyalgia will be recruited from tertiary health care establishments, specifically patients treated in the area of rheumatology, for eligibility assessment according to inclusion and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05283161
Start Date
April 15 2022
End Date
November 20 2022
Last Update
April 11 2022
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