Full-Spectrum Cannabis Extract 5:1 (CBD:THC): Oral 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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
45 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Ability to understand the informed consent form and study questionnaires
* Willingness and ability to attend scheduled visits and biological sample collections during the study follow-up period
Exclusion Criteria:
* 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
* Known hypersensitivity to cannabinoids or formulation excipients
* Clinically significant hepatic impairment, defined as aspartate aminotransferase or alanine aminotransferase greater than 3 times the upper limit of normal, or severe heart failure classified as New York Heart Association class III or IV
* History of substance use disorder that, in the investigator's judgment, may interfere with study participation
* Use of medications that may interfere with bone metabolism, including bisphosphonates, systemic corticosteroids, or sex hormones, within 6 months before enrollment
Primary outcome measure(s)
Change From Period Baseline in Chronic Pain Intensity on the Visual Analog Scale — At the baseline and end of each treatment period, approximately 6 months per period. 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.
Trial sites (1)
Facility
City
Region
Status
Projeto Shalom
São Paulo
São Paulo
More Associação Pan-Americana Multidisciplinar de Endocanabinologia trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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