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)

March 23, 2026 updated by: Federal University of Latin American Integration

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 significant side effects. Given this scenario, the project proposes the use of cannabinoids extracted from Cannabis sativa to modulate fibromyalgia symptoms, leveraging their analgesic, anti-inflammatory, and neuroprotective properties. The study is based on the hypothesis that the administration of phytocannabinoids may reduce fibromyalgia symptoms and improve patients' quality of life.

To achieve this, the protocol includes dose titration, starting with a CBD:THC concentration of 50:10 mg/day, with the possibility of gradual adjustment up to 125:25 mg/day, depending on clinical response. The experimental design includes patient follow-up at seven different time points over six months (T0 to T180). At T0, sociodemographic data will be collected, and several assessments will be conducted, including the Fibromyalgia Impact Questionnaire - Revised, Beck Depression Inventory, Pittsburgh Sleep Quality Index, Short Form-36, Epworth Sleepiness Scale, Beck Hopelessness Scale, NOVA Score, and the UKU Side Effects Rating Scale. Additionally, laboratory tests and polysomnography will be performed. In the subsequent follow-ups (T30, T60, T90, T120, T150, and T180), reassessments of clinical parameters will be conducted, with adjustments to the experimental product dosage as needed. Participant selection will include cisgender women with a confirmed diagnosis of fibromyalgia (according to the American College of Rheumatology criteria), while excluding cases with conditions that could interfere with treatment safety or evaluation, such as pregnancy, recent cannabinoid use, or severe cardiovascular diseases. In summary, the Fridinha Project aims to provide a cannabinoid-based therapeutic alternative for fibromyalgia management, intending to reduce the adverse effects of conventional treatments and significantly improve patients' quality of life. The results are expected to provide a scientific foundation for larger-scale research and support the development of public health policies to expand access to cannabis-based treatments within the Brazilian healthcare system.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Foz do Iguaçu, Paraná, Brazil, 85870-650
        • Universidade Federal da Integração Latino-Americana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire - Revisado (FIQr-Br)
Time Frame: 6 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 6 months
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)
Time Frame: 6 months
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
Time Frame: 6 months
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)
Time Frame: 6 month
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)
Time Frame: 6 months
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
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Latin American Integration

Collaborators

Associação Brasileira de Cannabis Medicinal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

August 20, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRIDINHA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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