FibromyalgiaPhase 1/2NCT07498023
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)
A Phase 1/2 study testing Cannabis in people with Fibromyalgia, run by Federal University of Latin American Integration at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2025to 20 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal da Integração Latino-Americana
Foz do Iguaçu, Paraná, 85870-650
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Cannabis
- Keywords
- Fibromyalgia, Pain, Pain management, Tetrahydrocannabinol, Cannabidiol.
- Medical subject headings
- Fibromyalgia, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP INTERVENTION | Experimental | 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. Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Sep 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Latin American Integration
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Brasileira de Cannabis Medicinal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498023
- Sponsor's protocol ID
- FRIDINHA
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07498023
- Acronym / sponsor ID
- FRIDINHA
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Pain management, Tetrahydrocannabinol, Cannabidiol.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Federal University of Latin American IntegrationUniversity, hospital or other
- Collaborators
- Associação Brasileira de Cannabis Medicinal
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GROUP INTERVENTION | Experimental | Drug: CannabisPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisPatients 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 | GROUP INTERVENTION |
Primary outcome
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 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Short Form-36 (SH-36)
Time frame: 6 months
UKU Side Effects Scale
Time frame: 6 months
Sleep Apnea Risk Assessment Questionnaire (STOP-Bang)
Time frame: 6 month
Life Events Checklist (LEC-5)
Time frame: 6 months
Fibromyalgia Rapid Screening Tool - FIRST
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabis in people with Fibromyalgia, run by Federal University of Latin American Integration at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire - Revisado (FIQr-Br) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.