A Randomized, Triple-Masked, Placebo-Controlled Crossover Trial of Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women

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.

Conditions

• Chronic Pain
• Fibromyalgia
• Osteoporosis
• Orofacial Pain

Interventions

DRUG

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.

Sponsors & Collaborators

• Mackenzie Presbiterian University, São Paulo, Brazil

  collaborator OTHER

• Associação Brasileira de Cannabis Medicinal

  collaborator OTHER

• Casa da Esperança de Santo André

  collaborator UNKNOWN

• Associação Pan-Americana Multidisciplinar de Endocanabinologia

  lead OTHER

Principal Investigators

• Alethéia B P Barbosa, PhD · Universidade Presbiteriana Mackenzie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-09-01

Completion

2027-12-01

Countries

• Brazil

Study Locations