Chronic pain disproportionately affects women and may coexist with impaired bone health, particularly during midlife and after menopause. The endocannabinoid system is involved in pain modulation and bone homeostasis; however, clinical studies that integrate pain outcomes, bone-related biomarkers, genetic variants, and salivary endocannabinoids remain limited.This randomized, triple-masked, placebo-controlled crossover trial will evaluate the effects of a full-spectrum medicinal cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 on chronic pain in women aged 45 to 80 years with chronic pain refractory to conventional treatment. Eighty participants will be randomly assigned to one of two treatment sequences: full-spectrum cannabis extract followed by matching placebo, or matching placebo followed by full-spectrum cannabis extract. The treatment periods, washout interval, and visit schedule will follow the final approved protocol.The primary outcome is change in chronic pain intensity measured using the Visual Analog Scale. Secondary outcomes include quality of life, sleep quality, functional impact, bone health biomarkers, bone mineral density measured by dualenergy X-ray absorptiometry, salivary endocannabinoids, the association of CB and TRPV genetic variants with treatment response, and adverse events. The study aims to generate evidence on the clinical effects and biological correlates of medicinal cannabis therapy in women with chronic pain.
Female sex, age 45 to 80 years
Moderate to severe chronic pain, defined as a pain score of at least 4 on a 0 to 10 Visual Analog Scale, persisting for more than 3 months
Documented inadequate response to at least 2 classes of analgesic treatments or non-pharmacological treatments
Willingness to abstain from smoked cannabis and non-study cannabinoid products during the study
Cognitive impairment that precludes understanding of the informed consent form or study questionnaires
Uncontrolled psychiatric condition, including uncontrolled psychotic disorder or bipolar disorder
Pregnancy, breastfeeding, or intention to become pregnant during the study
Current use of medicinal cannabis, smoked cannabis, or other cannabinoid products
Crossover
Full-Spectrum Cannabis Extract 5:1 (CBD:THC)
DrugOral softgel capsule containing full-spectrum medicinal cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1. The target daily dose is 25 milligrams of cannabidiol and 5 milligrams of tetrahydrocannabinol. Participants will receive the study product once daily in the evening, with gradual dose titration during the first 2 weeks of each active treatment period, according to the final approved protocol. The product will be administered for the duration of each protocol-defined active treatment period.
Change From Period Baseline in Chronic Pain Intensity on the Visual Analog Scale
Chronic pain intensity will be measured using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. The baseline score will be the mean pain intensity reported over the preceding 7 days. A clinical response is defined as a reduction of at least 30 percent from the baseline score of the corresponding treatment period.
Change From Period Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index.
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a self-reported instrument with a global score from 0 to 21. Higher scores indicate worse sleep quality.
Change From Period Baseline in Health-Related Quality of Life on the 36-Item Short Form Survey.
Health-related quality of life will be assessed using the Medical Outcomes Study 36-Item Short Form Survey (SF-36). Scores are calculated for 8 domains from 0 to 100; higher scores indicate better health-related quality of life.
Change From Period Baseline in Pain-Related Quality of Life on the WHOQOL-Pain Instrument.
Pain-related quality of life will be assessed using the Portuguese version of the WHOQOL-Pain instrument. Scoring and interpretation will follow the validated instrument manual.
Change From Period Baseline in Fibromyalgia Impact Questionnaire Score Among Participants With Fibromyalgia.
Functional impact among participants with a clinical diagnosis of fibromyalgia will be assessed using the Fibromyalgia Impact Questionnaire (FIQ). The scale will be scored according to the validated Portuguese version; higher scores indicate greater disease impact.
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Associação Pan-Americana Multidisciplinar de Endocanabinologia
Lead sponsor
Mackenzie Presbiterian University, São Paulo, Brazil
Collaborator
Associação Brasileira de Cannabis Medicinal
Collaborator
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