Cannabis, Fibromyalgia
Conditions
Keywords
cannabis, fibromyalgia, phytocannabinoids, cannabinoid
Brief summary
A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects. The active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.
Interventions
DRUGKL16-012
Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD
DRUGPlacebo
Placebo
Sponsors
Knop Laboratorios
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fibromyalgia based on ACR 2010 criteria * FIQ \> 39 (refractary symptoms) * Previous use of at least 2 conventional pharmacotherapies
Exclusion criteria
* History of substance use disorder * History of major psychiatric or cardiovascular diseases * Pregnancy * Urine THC (+)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fibromyalgia Impact Questionnaire (FIQ) score | Baseline to 12 weeks | Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fibromyalgia Impact Questionnaire (FIQ) score | Baseline to 2 weeks | Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms. |
| Change in Insomnia Severity Index (ISI) score | Baseline to 2 weeks | Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia. |
| Change in pain Visual Analog Scale (VAS) score | Baseline to 2 weeks | Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain. |
| Changes in plasma cytokines | Baseline to 12 weeks | Quantitative ELISA measurements of plasma levels of IL-6, IL-8, CXCL5, CXCL6, MCP-2, LAP TGFβ-1 and TNFα |
Outcome results
None listed