Could cannabis oil be a new key to chronic pain relief and stronger bones in women?
NCT ID NCT07783295
First seen Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This trial tests whether a daily oral cannabis extract with a 5:1 CBD-to-THC ratio can reduce chronic pain in women aged 45 to 80 who haven't found relief from standard treatments. Participants will receive either the cannabis extract or a placebo in a crossover design, allowing each person to experience both. The study measures pain intensity, quality of life, sleep, and bone health markers, including bone density and genetic factors. The goal is to see if this approach can improve pain and potentially offer insights into preventing osteoporosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Full-spectrum cannabis extract with a 5:1 CBD to THC ratio, taken as an oral softgel capsule
- What this could lead to
- If successful, this could offer a new option for women with hard-to-treat chronic pain, potentially improving pain, sleep, and quality of life while also shedding light on bone health.
- What could go wrong
- This is a small, early-stage trial, and results may not apply to everyone. Cannabis can cause side effects like dizziness or drowsiness, and the pain-relief effect may not be better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Projeto Shalom
São Paulo, São Paulo, 09130-040, Brazil
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Other studies related to the condition(s) this trial covers.
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