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Could cannabis ease fibromyalgia pain? new trial investigates

NCT ID NCT07498023

Symptom relief Sponsor: Federal University of Latin American Integration Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a full-spectrum cannabis extract containing CBD and THC in 36 women with fibromyalgia, a condition causing widespread pain, fatigue, and sleep problems. Participants will receive different doses over six months to see if it improves symptoms and quality of life. It is an early-stage, open-label trial, meaning everyone knows they are getting the treatment, so results are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabis extract (CBD and THC)
What this could lead to
If successful, this could point toward a new treatment option for fibromyalgia that reduces pain and improves quality of life with fewer side effects than current medications.
What could go wrong
This is a very small, early-phase pilot study with only 36 participants and no placebo group, so results may not be reliable or generalizable. The optimal dose and long-term safety are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

agnosia fibromyalgia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

Contacts and locations

Locations

  • Universidade Federal da Integração Latino-Americana

    Foz do Iguaçu, Paraná, 85870-650, Brazil

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