Cannabis extract for long-lasting pain and bone health in women
Tests a cannabis extract against placebo for chronic pain in women.
Plain-language title generated from the registry record
Registry title: Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 45 to 80 with moderate to severe chronic pain that has not improved with usual treatment. It tests a medicinal cannabis extract against a placebo.
- Age
- 45 to 80 years
- Sex
- Women only
- Disease stage
- Moderate to severe chronic pain, at least 4 on a 0 to 10 pain scale, lasting more than 3 months
- Earlier treatment
- Pain did not improve enough with at least 2 classes of pain medicine or non-drug treatments. No bisphosphonates, systemic corticosteroids or sex hormones within 6 months before joining.
Main reasons for not taking part
- Current use of medicinal cannabis, smoked cannabis or other cannabinoid products
- Pregnancy, breastfeeding, or plans to become pregnant during the study
- Uncontrolled psychiatric condition, such as psychotic disorder or bipolar disorder
- Significant liver problems or severe heart failure (NYHA class III or IV)
- Allergy to cannabinoids or to the ingredients of the product
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 80 years old?
Source: NCT07783295, who can take part
Where in Brazil
- Projeto ShalomSão Paulo, BrazilContact: Alethéia B P Barbosa, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Associação Pan-Americana Multidisciplinar de Endocanabinologia
- Trial code
- NCT07783295
- Record updated
- 26 August 2026
- Original description
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.Read full original descriptionShow less
Evaluation of Bone Turnover Biomarkers, CB2 and TRPV1 Polymorphisms as Potential Preventive Data in Osteoporosis and Perception of Improvement in Quality of Life in Women With Chronic Pain Treated With Medicinal Cannabis
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.
Inclusion: 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: Use of medications that may interfere with bone metabolism, including bisphosphonates, systemic corticosteroids, or sex hormones, within 6 months before enrollment; Cognitive impairment that precludes understanding of the informed consent form or study questionnaires; Uncontrolled psychiatric condition, including uncontrolled psychotic disorder or bipolar disorder; 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; Pregnancy, breastfeeding, or intention to become pregnant during the study; Current use of medicinal cannabis, smoked cannabis, or other cannabinoid products.