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Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women

Study acronym: ORION
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Collaborators: 3 to 2
    • Study title shortened, about 7 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07783295
Lead Sponsor Associação Pan-Americana Multidisciplinar de Endocanabinologia
Collaborators: Mackenzie Presbiterian University, São Paulo, Brazil, Associação Brasileira de Cannabis Medicinal
Conditions
(from sponsor)		 Chronic Pain, Fibromyalgia, Osteoporosis, Orofacial Pain
Related terms Chronic Pain, Facial Pain, Fibromyalgia, Osteoporosis
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov