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Clinical Trial NCT07498023 for Fibromyalgia is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA) Phase 1, Phase 2 36 Open-Label
Clinical Trial NCT07498023 is designed to study Treatment for Fibromyalgia. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on 15 September 2025, with plans to enroll 36 participants. Led by Federal University of Latin American Integration, it is expected to complete by 20 August 2026. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
The Fridinha Project is a pilot, multicenter, open-label clinical trial that will investigate the therapeutic effects of different CBD and THC dosages in modulating fibromyalgia, a syndrome characterized by widespread chronic pain, fatigue, sleep disturbances, and cognitive impairment. This condition primarily affects women between the ages of 34 and 60, and conventional treatment has shown limited efficacy and signi...Show More
Official Title
EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA)
Conditions
FibromyalgiaOther Study IDs
- FRIDINHA
NCT ID Number
Start Date (Actual)
2025-09-15
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-08-20
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Active, not recruiting
Keywords
Fibromyalgia
Pain
Pain management
Tetrahydrocannabinol
Cannabidiol.
Pain
Pain management
Tetrahydrocannabinol
Cannabidiol.
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGROUP INTERVENTION Patients will receive the cannabis-based product in the following CBD:THC doses: 50:10mg/day,75:15mg/day, 100:20mg/day, or 125:25mg/day. | Cannabis Patients will receive the cannabis-based product in the following CBD:THC doses: 50:10mg/day,75:15mg/day, 100:20mg/day, or 125:25mg/day. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Fibromyalgia Impact Questionnaire - Revisado (FIQr-Br) | It is a 21-item multiple-choice questionnaire that can be self-administered or administered by a researcher. This instrument aims to measure the impact of fibromyalgia on functional capacity, professional situation, psychological disorders, and physical symptoms. Its score is directly proportional to the impact of this pathology on quality of life and daily functioning, that is, the higher the score obtained, the worse the quality of life and the more compromised the patient's functioning.The score is: 0 good - 100 very bad | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pittsburgh Sleep Quality Index (PSQI) | A questionnaire consisting of 10 varied open-ended and multiple-choice questions that can be self-administered or administered by a researcher, aims to measure sleep quality and disorders. Its score is tabulated as follows: 0-4 good sleep quality, 4-10 poor sleep quality, and \>10 presence of sleep disorder. This instrument will be applied at times T0 to T180. | 6 months |
Short Form-36 (SH-36) | A 36-item multiple-choice questionnaire that can be self-administered or administered by a researcher. Its main objective is to measure the impact of a certain pathology on the patient's quality of life, assessing both positive and negative aspects of health. It is scored in eight functional domains, which cannot be added together or averaged, with results ranging from 0 (worst quality of life) to 100 (best quality of life) | 6 months |
UKU Side Effects Scale | A 48-item multiple-choice questionnaire to be administered by a researcher aims to create a method for accessing and understanding the impact of adverse effects during pharmacological treatment. Its score is directly proportional to the impact of the pathology on the patient's quality of life and daily functioning.The score is: 0 good - 144 very bad | 6 months |
Sleep Apnea Risk Assessment Questionnaire (STOP-Bang) | An 8-item questionnaire with dichotomous responses (yes/no), which can be self-administered or administered by a researcher, used to screen for risk of obstructive sleep apnea. Scoring is done by assigning 1 point for each "yes" answer, with a total score ranging from 0 to 8. Scores from 0 to 2 indicate low risk, from 3 to 4 indicate intermediate risk, and scores equal to or greater than five indicate high risk for apnea. The identification of patients with this disorder is essential in studies with medications that promote sleep, as these drugs can aggravate apnea and increase the risk of adverse events | 6 month |
Life Events Checklist (LEC-5) | A 17-item questionnaire that investigates whether there has been exposure to potentially traumatic events and how this occurred throughout life, in this sense, classifying the experience for each item as direct, witnessing, knowledge from third parties, or occupational exposure-in order to allow for different forms of contact for the same stressful event.This questionnaire is scored based on the sum of the items marked, with each item equivalent to 1 point. In addition, information can be extracted from the domains of accidental/injury trauma (items 1, 2, 3, 4, and 12), victimization trauma (items 6, 8, and 9), and predominant life-threatening trauma (items 5,7, 10, 11, 13, 14, 15, and 16). The score is: 0-68, higher scores = greater exposure to traumatic events. | 6 months |
Fibromyalgia Rapid Screening Tool - FIRST | It is a brief self-administered screening questionnaire composed of 6 yes/no items. This instrument is designed to help identify patients who may have fibromyalgia among individuals presenting with chronic widespread pain. The questions assess characteristic symptoms of fibromyalgia, such as diffuse pain, fatigue, sleep disturbances, and sensitivity to stimuli. The score corresponds to the number of positive responses, with higher scores indicating a greater likelihood of fibromyalgia. | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
I. Have a medical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria\[29\]; II. Be cisgender women; III. Be literate; IV. Be aged between 18 and 60; V. Score ≥ 5 points on the Fibromyalgia Rapid Screening Tool (FIRST); VI. Reside in the state of Paraná, Brazil.
I. Not being available on a monthly basis to attend in person at the center that has been accredited to carry out follow-up consultations; II. Being pregnant or breastfeeding; III. Having secondary fibromyalgia (fibromyalgia associated with rheumatoid arthritis, systemic lupus erythematosus, or autoimmune disease); IV. Being at risk for sleep apnea (≥5 points on the STOP-Bang Questionnaire); V. Having advanced musculoskeletal disorders; VI. Having severe neuropathies and/or known severe cardiovascular diseases, such as stroke, acute coronary syndrome, cardiac arrhythmias, and myocardial infarction; VII. Having a diagnosis of bipolar disorder, or having first-degree relatives VII. Have a diagnosis of bipolar disorder, or have first-degree relatives diagnosed with psychosis and schizophrenia; VIII. Reported previous use of cannabinoids by any route of administration in the last 30 days; IX. Use of clobazam and/or sympathomimetic and anticholinergic medications; X. Diagnosis of alcohol dependence or opioid use; XI. Women who do not agree to sign the informed consent form.
Federal University of Latin American IntegrationAssociação Brasileira de Cannabis MedicinalNo contact data.
1 Study Locations in 1 Countries
Paraná
Universidade Federal da Integração Latino-Americana, Foz do Iguaçu, Paraná, 85870-650, Brazil