A Phase 2 interventional study of Full-Spectrum Cannabis Extract 5:1 (CBD:THC) in Chronic Pain, Fibromyalgia and Osteoporosis, sponsored by Associação Pan-Americana Multidisciplinar de Endocanabinologia. Not yet recruiting at 1 site in Brazil. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Associação Pan-Americana Multidisciplinar de Endocanabinologia · Phase 2, Interventional, and Treatment
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Associação Pan-Americana Multidisciplinar de Endocanabinologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
Time frame: At the baseline and end of each treatment period, approximately 6 months per period.
Change From Period Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: At baseline and at the final study visit, approximately 12 months after enrollment.
Change From Period Baseline in Serum Bone Turnover Biomarkers.
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.
Time frame: At baseline and at protocol-defined follow-up visits through final study completion, approximately 12 months.
Association of CB2 and TRPV1 Genetic Variants With Pain Treatment Response.
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.
Time frame: Genotyping at baseline; association with pain response through the end of each treatment period, approximately 12 months.
Change From Baseline in Salivary Endocannabinoid Concentrations.
Salivary concentrations of anandamide, 2-arachidonoylglycerol, palmitoylethanolamide, and oleoylethanolamide will be quantified by liquid chromatography-tandem mass spectrometry and reported in nanograms per milliliter.
Time frame: Use the final collection schedule; do not submit this entry until the protocol is harmonized as baseline-only or serial sampling.
Number of Participants With Treatment-Emergent Adverse Events.
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.
Time frame: From first study product administration through the end of each treatment period, approximately 6 months per period.
Change From Period Baseline in Hepatic and Renal Safety Laboratory Values.
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.
Time frame: At baseline and at protocol-defined follow-up visits through final study completion, approximately 12 months.
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Studies of the drug tested here: Dronabinol
Associação Pan-Americana Multidisciplinar de Endocanabinologia