Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT05283161
Eligibility 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:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05283161
Study Brief:
Protocol Section:
NCT05283161