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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT05939466
Eligibility Criteria:
Inclusion Criteria:
* Informed written consent;
* Age \>18 years old;
* Diagnosis of FM confirmed by a rheumatologist;
* Persistent pain symptoms for at least three months without complaints that may otherwise explain the pain condition;
* Persistent pain syndrome on conventional therapy with opioids or non-steroidal anti- inflammatory drugs
* Not having taken medical cannabis in the previous year since the start of the study
* Stopping drug therapy during the trial with cannabis (Bedrocan®).
Exclusion Criteria:
* Specific contraindications to cannabinoid use;
* Pain syndrome not associated with FM
* Major comorbidities like renal impairment, severe liver disease, chronic hepatitis C, history of alcohol or drug addiction
* The presence of cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy.
* Pregnant or planning pregnancy women and breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05939466
Study Brief:
Protocol Section:
NCT05939466