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

NCT07783295 | Not Yet Recruiting Phase 2

• 1 other identifier: UPM-BONE-RELIEF-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

medical cannabis; cannabidiol; tetrahydrocannabinol; bone turnover; CB1 receptor; CB2 receptor; TRPV1 receptor; Women; crossover trial; bone mineral density; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At the baseline and end of each treatment period, approximately 6 months per period.

Secondary Outcomes (10)

• Change From Period Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index.

  At baseline and at 3 and 6 Months each treatment period.

• Change From Period Baseline in Health-Related Quality of Life on the 36-Item Short Form Survey.

  At baseline and at Months 3 and 6 of each treatment period.

• Change From Period Baseline in Pain-Related Quality of Life on the WHOQOL-Pain Instrument.

  At baseline and at Months 3 and 6 of each treatment period.

• Change From Period Baseline in Fibromyalgia Impact Questionnaire Score Among Participants With Fibromyalgia.

  At baseline and at Months 3 and 6 of each treatment period.

• Change From Baseline in Bone Mineral Density Measured by Dual-Energy X-Ray Absorptiometry.

  At baseline and at the final study visit, approximately 12 months after enrollment.

Study Arms (2)

Cannabis Extract Then Placebo

EXPERIMENTAL

Participants receive oral full-spectrum cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 during Treatment Period 1, followed by the protocol-defined washout interval and matching placebo during Treatment Period 2.

Drug: Full-Spectrum Cannabis Extract 5:1 (CBD:THC)

Placebo Then Cannabis Extract

PLACEBO COMPARATOR

Participants receive matching placebo during Treatment Period 1, followed by the protocol-defined washout interval and oral full-spectrum cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 during Treatment Period 2.

Drug: Full-Spectrum Cannabis Extract 5:1 (CBD:THC)

Interventions

Full-Spectrum Cannabis Extract 5:1 (CBD:THC) DRUG

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.

Cannabis Extract Then Placebo; Placebo Then Cannabis Extract

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: The study focuses on women because chronic pain and osteoporosis-related bone health risk disproportionately affect women during midlife and after menopause.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associação Pan-Americana Multidisciplinar de Endocanabinologia: lead
• Associação Brasileira de Cannabis Medicinal: collaborator
• Mackenzie Presbiterian University, São Paulo, Brazil: collaborator

Study Sites (1)

Projeto Shalom

São Paulo, São Paulo, 09130-040, Brazil

Location

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MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Osteoporosis; Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alethéia B P Barbosa, PhD

  Universidade Presbiteriana Mackenzie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alethéia B P Barbosa, PhD

CONTACT

+55 11 97247-1484; abpablos@gmail.com

José Wilson N V Andrade, MD

CONTACT

+55 11 971905328; dr.jwilsonandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study uses triple masking. Participants, clinical care providers, and investigators involved in participant assessment and study conduct will remain unaware of treatment assignment. The statistician will analyze coded treatment groups until the prespecified unmasking procedure is completed. Study products and placebo will be matched in presentation and dispensing procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two crossover sequences. Sequence A will receive full-spectrum cannabis extract during Period 1 and matching placebo during Period 2. Sequence B will receive matching placebo during Period 1 and full-spectrum cannabis extract during Period 2. The treatment periods will be separatedby a protocol-defined washout interval. Randomization will use computer-generated permuted blocks of 4 with allocation concealment through opaque, sealed envelopes.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)