Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women (ORION)
24. srpna 2026 aktualizováno: Associação Pan-Americana Multidisciplinar de Endocanabinologia
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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
This is a randomized, triple-masked, placebo-controlled crossover clinical trial conducted in women aged 45 to 80 years with moderate to severe chronic pain that has persisted for at least 3 months and has not responded adequately to conventional pharmacological or non-pharmacological treatments.
Participants will be randomlyallocated in permuted blocks to one of two treatments sequences.
Sequence A will receive a full-spectrum medicinal cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 during the first treatment period, followed by a protocol-defined washout interval and matching placebo during the second treatment period.
Sequence B will receive matching placebo during the first treatment period, followed by the washout interval and the full-spectrum medicinal cannabis extract during the second treatment period.
The study product will be administered orally as softgel capsules.
The target daily dose is 25 milligrams of cannabidiol and 5 milligrams of tetrahydrocannabinol. Dose titration during the first 2 weeks of each active treatment period will follow the final approved protocol.Participants, care providers, investigators, and outcome assessors will remain masked to treatment assignment as operationally applicable.
Randomization will use a computer-generated sequence with permuted blocks of 4 and allocation concealment through opaque, sealed envelopes.
The product and matching placebo will be supplied in indistinguishable presentations.Clinical evaluations will include pain intensity, quality of life, functional impact, sleep quality, concomitant medications, adherence, and adverse events.
Laboratory assessments will include safety tests, selected bone metabolism biomarkers, inflammatory markers, and oxidative stress biomarkers.
Bone mineral density and body composition will be assessed using dualenergy X-ray absorptiometry at protocol-defined baseline and final visits.
Genetic analysis will evaluate CB and TRPV variants.
Salivary anandamide, 2-arachidonoylglycerol, palmitoylethanolamide, and oleoylethanolamide will be quantified using liquid chromatography coupled with tandem mass spectrometry according to the final sample collection schedule.The primary efficacy analysis will compare pain outcomes across cannabis and placebo treatment periods while accounting for the crossover design.
Secondary analyses will evaluate changes in patient-reported outcomes and biomarkers, treatment safety, and associations between genetic variants or salivary endocannabinoid profiles and treatment response.
Typ studie
Intervenční
Zápis (Odhadovaný)
80
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: José Wilson N V Andrade, MD
- Telefonní číslo: +55 11 971905328
- E-mail: dr.jwilsonandrade@gmail.com
Studijní záloha kontaktů
- Jméno: Alethéia B P Barbosa, PhD
- Telefonní číslo: +55 11 97247-1484
- E-mail: abpablos@gmail.com
Studijní místa
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São Paulo
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São Paulo, São Paulo, Brazílie, 09130-040
- Projeto Shalom
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Kontakt:
- Alethéia B P Barbosa, PhD
- Telefonní číslo: +55 11 97247-1484
- E-mail: abpablos@gmail.com
-
Kontakt:
- José Wilson N V Andrade, MD
- Telefonní číslo: + 55 11 971905328
- E-mail: dr.jwilsonandrade@gmail.com
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Cannabis Extract Then Placebo
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.
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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.
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Komparátor placeba: Placebo Then Cannabis Extract
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.
|
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Period Baseline in Chronic Pain Intensity on the Visual Analog Scale
Časové okno: At the baseline and end of each treatment period, approximately 6 months per period.
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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.
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At the baseline and end of each treatment period, approximately 6 months per period.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Period Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index.
Časové okno: At baseline and at 3 and 6 Months each treatment period.
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Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a self-reported instrument with a global score from 0 to 21.
Higher scores indicate worse sleep quality.
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At baseline and at 3 and 6 Months each treatment period.
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Change From Period Baseline in Health-Related Quality of Life on the 36-Item Short Form Survey.
Časové okno: At baseline and at Months 3 and 6 of each treatment period.
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Health-related quality of life will be assessed using the Medical Outcomes Study 36-Item Short Form Survey (SF-36).
Scores are calculated for 8 domains from 0 to 100; higher scores indicate better health-related quality of life.
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At baseline and at Months 3 and 6 of each treatment period.
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Change From Period Baseline in Pain-Related Quality of Life on the WHOQOL-Pain Instrument.
Časové okno: At baseline and at Months 3 and 6 of each treatment period.
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Pain-related quality of life will be assessed using the Portuguese version of the WHOQOL-Pain instrument.
Scoring and interpretation will follow the validated instrument manual.
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At baseline and at Months 3 and 6 of each treatment period.
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Change From Period Baseline in Fibromyalgia Impact Questionnaire Score Among Participants With Fibromyalgia.
Časové okno: At baseline and at Months 3 and 6 of each treatment period.
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Functional impact among participants with a clinical diagnosis of fibromyalgia will be assessed using the Fibromyalgia Impact Questionnaire (FIQ).
The scale will be scored according to the validated Portuguese version; higher scores indicate greater disease impact.
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At baseline and at Months 3 and 6 of each treatment period.
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Change From Baseline in Bone Mineral Density Measured by Dual-Energy X-Ray Absorptiometry.
Časové okno: At baseline and at the final study visit, approximately 12 months after enrollment.
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Bone mineral density and body composition will be assessed using dual-energy X-ray absorptiometry (DXA).
Bone mineral density will be reported in grams per square centimeter and interpreted using T-scores according to applicable clinical criteria.
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At baseline and at the final study visit, approximately 12 months after enrollment.
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Change From Period Baseline in Serum Bone Turnover Biomarkers.
Časové okno: At baseline and at protocol-defined follow-up visits through final study completion, approximately 12 months.
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Serum bone health biomarkers will include the final protocol-specified panel of alkaline phosphatase, total and ionized calcium, 25-hydroxyvitamin D, and parathyroid hormone.
If procollagen type 1 N-terminal propeptide and C-terminal telopeptide are retained in the final protocol, they should be listed here explicitly.
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At baseline and at protocol-defined follow-up visits through final study completion, approximately 12 months.
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Association of CB2 and TRPV1 Genetic Variants With Pain Treatment Response.
Časové okno: Genotyping at baseline; association with pain response through the end of each treatment period, approximately 12 months.
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Genotyping of cannabinoid receptor 2 (CB2/CNR2) and transient receptor potential vanilloid 1 (TRPV1) variants will be performed using real-time polymerase chain reaction.
Associations between genotype or haplotype and the prespecified Visual Analog Scale pain response will be evaluated.
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Genotyping at baseline; association with pain response through the end of each treatment period, approximately 12 months.
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Change From Baseline in Salivary Endocannabinoid Concentrations.
Časové okno: Use the final collection schedule; do not submit this entry until the protocol is harmonized as baseline-only or serial sampling.
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Salivary concentrations of anandamide, 2-arachidonoylglycerol, palmitoylethanolamide, and oleoylethanolamide will be quantified by liquid chromatography-tandem mass spectrometry and reported in nanograms per milliliter.
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Use the final collection schedule; do not submit this entry until the protocol is harmonized as baseline-only or serial sampling.
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Number of Participants With Treatment-Emergent Adverse Events.
Časové okno: From first study product administration through the end of each treatment period, approximately 6 months per period.
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Adverse events will be collected through clinical visits and weekly remote pharmacotherapeutic monitoring.
Events will be classified by severity, seriousness, relatedness to study treatment, and treatment period.
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From first study product administration through the end of each treatment period, approximately 6 months per period.
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Change From Period Baseline in Hepatic and Renal Safety Laboratory Values.
Časové okno: At baseline and at protocol-defined follow-up visits through final study completion, approximately 12 months.
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Safety laboratory assessments will include protocol-specified hepatic and renal tests, including aspartate aminotransferase, alanine aminotransferase, urea, and creatinine.
Results will be reported in standard laboratory units.
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At baseline and at protocol-defined follow-up visits through final study completion, approximately 12 months.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alethéia B P Barbosa, PhD, Universidade Presbiteriana Mackenzie
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. září 2027
Dokončení studie (Odhadovaný)
1. prosince 2027
Termíny zápisu do studia
První předloženo
20. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
20. srpna 2026
První zveřejněno (Aktuální)
24. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Nemoci kostí
- Nemoci pohybového aparátu
- Nemoci nervového systému
- Svalová onemocnění
- Neuromuskulární onemocnění
- Revmatická onemocnění
- Metabolické choroby
- Nemoci kostí, Metabolické
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Fibromyalgie
- Chronická bolest
- Osteoporóza
- Bolest v obličeji
Další identifikační čísla studie
- UPM-BONE-RELIEF-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .